Complimentary Service of Audreysnetwork · 9/9/2012 · Sr. Manager, Sales Training and...

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Jobs That Crossed My Desk Through Sept. 9, 2012 Complimentary Service of Audreysnetwork.com

Sept. 9, 2012

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. *************************************************************************** Apply on company website Sr. Manager, Sales Training and Development, KI Franchise Onyx Pharmaceuticals - REMOTE (San Francisco Bay Area) Job Description Summary The Senior Manager, Sales Training and Development—KI Franchise will be responsible for working with the Director, Sales Training and Development—KI Franchise to develop and implement a comprehensive “best in class” oncology sales training program that encompasses date-of-hire for new sales associates through ongoing training for experienced sales associates . The plan should include innovative training techniques using the most technically advanced communication tools as well as adult learning concepts. Content should include home study, sales call modeling, computer training, company orientation, product orientation, frequent assessments, speaker program training, advanced selling skills, drug reimbursement training, territory planning training, and advanced institutional medical practice training. Essential/Primary Duties, Functions and Responsibilities:

Implement Sales Training and Development annual plan; strategies, goals, programs and management of expenses in line with Operating Plan

Responsible for the development and execution of innovative and comprehensive sales training programs that will optimize performance-results of the Onyx Sales Team

Effective and synergistic collaboration with Marketing/Product Strategy, Sales Leadership, Medical Affairs and Compliance is required

Update training programs and curriculum as necessary, in order to adapt to changes that occur in the commercial environment and remain “best in class”

Responsible for the development and execution of innovative and comprehensive workshops as part of Regional and National Sales Team meetings

Effective management, solicitation and collaboration with external partners and vendors.

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Ensure that all training initiatives and programs are fully supported and documented with Onyx Compliance Standards

Partner with Senior Sales Leadership to fully leverage Onyx Representative Development System(s)

Attend major oncology and associated medical meetings, such as ASCO, AASLD, DDW, Chemotherapy Foundation, etc, as well as training development meetings like SPBT

Frequent field visits with new and experienced sales professionals to identify training gaps

Other duties as assigned Desired Skills & Experience Requirements Work Experience:

5-10 years oncology experience, including solid tumors Oncology sales experience required Training experience a plus DM experience a plus

Management of Staff: No direct reports upon hire

Location: Field-based position

Functional/Technical Knowledge & Skills: Proactive and strategic thinking with the ability to formulate, develop and execute

comprehensive plans Exceptional oral and written communication skills (via PowerPoint, Word, Excel, and

Outlook) Strong understanding of training technologies Excellent organizational & project management skills; ability to manage multiple

projects simultaneously Excellent problem-solving and management skills Ability to manage projects within budget Ability to manage vendors / contractors Exceptional negotiation, facilitation, presentation, and decision-making skills Ability to communicate with senior management Dynamic, self-starter with strong ability to influence

Customer & Industry Knowledge: Clinical Acumen – the ability to comprehend and effectively communicate complex

clinical data in a meaningful and impactful way. The ability to evolve data into messages

Oncology Business Acumen - demonstrated knowledge and successful experience in navigating the complex oncology business environment. Understanding circumstances and issues that can impede customers/patients access to Onyx products and services.

Ensures innovative Sales Training programs and approaches. Consistently updates all Onyx Training based on commercial needs and environment.

Experience effectively establishing & managing relationships with customers Education/Training:

Bachelors Degree required MBA or other Master’s degree a plus Scientific background preferred

License/Certification Required: None required Membership in the Society of Pharmaceutical and Biotech Trainers a plus

Other Requirements: Ability to travel up to 50% of the time, including monthly visits to home office

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Creative: generates new and unique ideas Resourceful: ability to use limited resources to execute ideas and plans High degree of collaboration and influence management skills

Competencies Business Acumen – recognizes business opportunities and identifies tactical plan to

effectively execute Planning – accurately scopes out length and difficulty of tasks and projects Process management – understanding processes necessary to optimally execute; well-

organized Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted: September 7, 2012 Type: Full-time Experience: Mid-Senior level Functions: Training Industries: Pharmaceuticals Job ID: 3708180 ************************************************************************* Please apply on-line at www.cepheid.com for all positions listed. Buyer Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description As a Buyer, you will manage the large volume placement of non-production and capital purchase requirements while optimizing corporate spend through negotiations on price, transportation, warranty and other related aspects. Complete purchasing activities for development and engineering departments to acquire materials and services in a cost effective and timely manner.

Assist internal customers on general inquiries / deliverables pertaining to placed orders for goods / services, invoice reconciliation and general procurement related issues.

Maintain Purchasing Card and other reconciliation follow up with A/P group. Ensure that RTS materials are processed in a timely manner with documentation

provided to A/P and supplier. Communication with supplier base to ensure that Cepheid Purchasing and Quality

requirements are clearly understood. Acquire and maintain a general technical understanding of products and services

purchased. May perform cost analysis and volume planning for blanket or standing requirements. Obtain materials, components, equipment and services. Assist in the development new supply sources where vendors and suppliers are

inadequate. Support the Cepheid Supplier Diversity Program through the active sourcing, selection

and purchasing activity with Small, Minority, and Woman-Owned Businesses. Provide support to other members of the Purchasing group in supporting various

procurement and department projects and deliverables. Requires a Bachelors degree or equivalent with a minimum of 2 years related

experience in a diagnostic or pharmaceutical environment. Experience working with QAD or other inventory management systems.

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Candidate should be familiar with raw materials used in biomedical device, pharmaceutical manufacturing.

Candidate should also be experienced with SOP's, GMP, JIT, MRP and should have experience with APICS principles.

Candidate should be comfortable and adept at Word and Excel. Desired Skills & Experience

Requires a Bachelors degree or equivalent with a minimum of 2 years related experience in a diagnostic or pharmaceutical environment.

Experience working with QAD or other inventory management systems. Candidate should be familiar with raw materials used in biomedical device,

pharmaceutical manufacturing. Candidate should also be experienced with SOP's, GMP, JIT, MRP and should have

experience with APICS principles. Candidate should be comfortable and adept at Word and Excel.

Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law.

Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: September 6, 2012 Type: Full-time Experience: Mid-Senior level Functions: Administrative Industries: Biotechnology Employer Job ID: 3130 Job ID: 3693887 ____________________________________________________________ Director, Logistics Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description The Director is responsible for leading the Distribution and Warehousing operations. The position has responsibility for implementing and administering all systems and procedures to control inventories and customer orders, as well as insuring the efficient flow of all materials necessary for production and all support functions. Includes initiating improvements in logistics operation and facilitates strategic outlook that will better serve all stakeholders. Additionally, the incumbent is responsible for Transportation and Customs Compliance and Management. This position is responsible for inventory control, domestic and international transportation management, distribution analysis and reporting, as well as, capital project management for Warehousing and Distribution. These activities include all personnel recruiting/development and budgeting.

Initial focus on the development of a Traffic function within the organization to support increased global distribution activities.

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Administers and directs the implementation of departmental policies & procedures in accordance with Government (DEA, cGMP, FDA,) and Company Policies, Procedures, Goals and Objectives.

Directs the integrity of inventory accuracy for multiple business units handled throughout the supply chain in order to support financial and business strategies and objectives.

Directs the preparation and administration of the operating and expense budgets, freight expense budgets, and group capital project budgets, in accordance purchasing policies of the company.

Develops and implements long terms strategies for Customs, DEA, and Transportation compliance.

Direct the Warehousing and Distribution compliance with all State distribution and warehousing licensing necessary to support customer requirements.

Directs and administers the selection and performance of freight carriers to maximize the service & security to our domestic and international customers.

Directs the development of technical training programs to support Warehousing and Distribution operations and ensures that all employees are trained appropriately to perform their job functions in order to maximize their efficiency and productivity.

Bachelor's degree in Logistics, Supply Chain, Business Administration or Engineering or equivalent experience

Minimum 7 years' experience of logistics, materials management, warehousing and distribution, or supply chain management with at least 5 years people leadership is required.

Demonstrated knowledge and application of FDA, DEA, and DOT standards and regulations. Knowledge and application of cGMP and 21 CFR Parts 210 & 211 is highly preferred.

Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Familiar with the correct handling, storage and disposal of raw materials used in

biomedical device, pharmaceutical manufacturing Ability to operate warehouse equipment including but not limited to forklift and pallet

jack Excellent interpersonal and communication skills, both written and verbal, as well as

high ethical standards Proven business/financial acumen, including demonstrated ability to motivate,

influence, solve complex problems, and drive change at all levels of the organization. Proven ability to work on cross-functional, multi-cultural teams Proven ability to meet deadline in a fast paces changing environment Excellent organizational skills with the ability to coordinate and implement team

projects Desired Skills & Experience

Bachelor’s degree in Logistics, Supply Chain, Business Administration or Engineering or equivalent experience

Minimum 7 years’ experience of logistics, materials management, warehousing and distribution, or supply chain management with at least 5 years people leadership is required.

Demonstrated knowledge and application of FDA, DEA, and DOT standards and regulations. Knowledge and application of cGMP and 21 CFR Parts 210 & 211 is highly preferred.

Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems

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Familiar with the correct handling, storage and disposal of raw materials used in biomedical device, pharmaceutical manufacturing

Ability to operate warehouse equipment including but not limited to forklift and pallet jack

Excellent interpersonal and communication skills, both written and verbal, as well as high ethical standards

Proven business/financial acumen, including demonstrated ability to motivate, influence, solve complex problems, and drive change at all levels of the organization.

Proven ability to work on cross-functional, multi-cultural teams Proven ability to meet deadline in a fast paces changing environment Excellent organizational skills with the ability to coordinate and implement team

projects Preferred Qualifications •CPM/APICS certification •MBA or MS in Logistics, Engineering or Supply Chain •International/domestic traffic experience •5 to 8 years demonstrated experience in a logistics leadership capacity of multiple facilities in pharmaceutical or biotechnology industry Physical Demands •Ability to lift up to 50 pounds Please apply on-line at www.cepheid.com. Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law. Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: September 4, 2012 Type: Full-time Experience: Director Functions: Product Management Industries: Biotechnology Employer Job ID: 3121 Job ID: 3684289 _________________________________________________________________ Inventory Control Manager Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description Responsibilities include activities related to the receiving, storing, managing of materials and finished goods.

Ensures materials are received from proper vendors, that they are delivered to inventory, and that finished goods are packaged according to specification and shipped in a timely manner

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Ensures the security and accountability of materials and goods using established inventory control procedures

Ensures materials are available to meet production schedules and/or products are shipped as per marketing schedules

Establishes and modifies operational methods and procedures for inventory management, cycle counting and physical inventories

Maintains documentation to support compliance, effectiveness and efficiency of department activities

Responsible for ensuring that the warehouse is operating under strict GMP guidelines Uses appropriate GMP/ISO requirements, processes and operational policies in selecting

methods and techniques for obtaining solutions Selects, develops and evaluates personnel to ensure the efficient operation of the

function Provides guidance to subordinates within the latitude of established company policies Acts as advisor to subordinates to meet schedules and/or resolve technical problems Anticipates, communicates and resolves internal and external issues that could affect

warehouse optimization Continuously achieves good customer service while following guidelines to support best

business practices Works on issues of diverse scope where analysis of situation or data requires evaluation

of a variety of factors, including an understanding of current business trends May have budget responsibilities Bachelors degree or equivalent experience 5 to 8 years experience in a supervisory or management capacity Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Strong working knowledge of GMP's and Code of Federal Regulations related to

inventory control Familiar with the correct handling, storage and disposal of raw materials used in



high ethical standards Capability to manage multiple priorities, organize complex requests, and resolve issues

creatively Excellent organizational skills with the ability to coordinate and implement team

projects Desired Skills & Experience

Bachelors degree or equivalent experience 5 to 8 years experience in a supervisory or management capacity Experience with QAD MFG/PRO or equivalent ERP system Good computer skills to complete warehousing transactions with ability to operate

effectively within multiple software applications and multiple inventory systems Strong working knowledge of GMP’s and Code of Federal Regulations related to

inventory control Familiar with the correct handling, storage and disposal of raw materials used in



high ethical standards

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Capability to manage multiple priorities, organize complex requests, and resolve issues creatively

Excellent organizational skills with the ability to coordinate and implement team projects

Preferred Qualifications • CPM/APICS certification is preferred • International/domestic traffic experience preferred Physical Demands Ability to lift up to 50 pounds Please apply on-line at www.cepheid.com. Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law. Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: August 30, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Biotechnology Employer Job ID: 3117 Job ID: 3661647 ______________________________________________ Product Transfer Scientist Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description The Product Transfer Scientist will combine knowledge of basic molecular biology, real-time PCR, fluidics, and a technical understanding of Cepheid systems to play a key role in product sustaining and support within the Product Transfer group. Lead the Manufacturing, Quality and Planning Departments in assuring the continued production of cost-effective quality products. Identify and implement streamlined and improved processes. Occasionally lead activities of junior staff.

Successfully implement assay/process/product improvements in Production, including: o Project planning and timeline management o Risk assessments o Costing o Training of personnel, as required o Implementation of all supporting documentation (BOMs, SOPs, worksheets, etc.) o Updating design history and other documentation

Design and execute validation/qualification activities on reagents, parts or processes. Coordination of multidisciplinary teams is often required. Act as the technical lead representing Operations in project team meetings.

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Provide coordination of Operation activities as needed to support projects. Provide technical support to the Manufacturing, Quality and Materials/Planning

Departments which may involve assessment of reagent formulations, process or test method development and/or troubleshooting existing product performance issues within the organization.

Lead investigations within production; design laboratory experiments and execute hands-on when needed, to assist in troubleshooting, process development or improvement activities.

Master's degree in Life Science or a related discipline with 6+ years of relevant professional experience. Or, Ph.D. in Life Science or a related discipline with 4+ years of relevant professional experience.

Track record of successful project leadership and cross-functional project management in a regulated industry

Experience working in a regulated industry such as biotechnology, medical device, etc. Excellent organizational and communication skills (oral and written) Ability to work independently and provide effective updates at executive level Ability to successfully lead multiple projects simultaneously towards completion within

short deadlines Desired Skills & Experience

Master's degree in Life Science or a related discipline with 6+ years of relevant professional experience. Or, Ph.D. in Life Science or a related discipline with 4+ years of relevant professional experience.

Track record of successful project leadership and cross-functional project management in a regulated industry

Experience working in a regulated industry such as biotechnology, medical device, etc. Excellent organizational and communication skills (oral and written) Ability to work independently and provide effective updates at executive level Ability to successfully lead multiple projects simultaneously towards completion within

short deadlines Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law. Company Description Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Additional Information Posted: August 27, 2012 Type: Full-time Experience: Mid-Senior level Functions: Science Industries: Broadcast Media Employer Job ID: 3023 Job ID: 3640228

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*********************************************************************** Posted by Nancy Symonds, President, NJS Recruiting Services SR. CRAs - HOME BASED POSITION - ONCOLOGY We are seeking 2 experienced CRAs for a CRO that specializes in oncology trials. The person can be based in any Western State but the Bay Area is a preference as the hiring manager is based here. Must be able to travel 50% and oncology experience is required. Thank you for forwarding this info to clinical professionals you know. ************************************************************************* Posted by Connie Andrews, Vice President, Global Services at Pharm-Olam International & UC Berkeley extension Biosciences Instructor Full time and contract CRA positions with Pharm-Olam International. Send resume to: [email protected] ********************************************************************** Frauke Schorr, Ph.D., Team and Leadership Development | Communication | Performance & Productivity, Centered Leadership Institute Seeking Independent Sales Contractor for Ambitious Boutique Corporate Consulting/Training Company This opening is a great opportunity for a business development representative with strong sales drive and self-starter attitude. We are looking to you to find creative and effective ways to expand our client portfolio. Background in sales is a must as well as a genuine interest in the field of corporate learning and development. A background or existing client relationships in the target customer base of Live Sciences or Energy is highly desired. Other customer bases are considered. Centered Leadership Institute is an ambitious boutique corporate training and leadership development company based in San Francisco Bay Area. We are passionate about helping teams and individuals in mid-sized and large companies become more effective at work, build stronger teams, and develop leadership skills. Out differentiator is going beyond simply teaching an understanding of new skills and helping clients to integrate new skills successfully into daily routines for increased productivity and efficiency. We "walk the talk": Not only are we passionate about making a difference to corporations but we also believe in what we teach and we live it. We are looking for someone who aligns with our philosophies. We are looking for a commission-only independent contractor. We have a differentiated product and are looking for the right person to bring this to a wider marketplace. The ideal candidate will have • A friendly, easy, and open attitude towards clients and team members • A corporate demeanor with an empathetic and polite angle • Able to effectively communicate in English, in both written and oral forms • Be persistent in finding new clients and nurturing existing relationships without giving the client the feeling of being 'sold to' • Understands that listening to clients' needs is an important skill for a good sale • Creative and passionate in promoting Centered Leadership Institute's services • Have a strong interest in learning and growing. Do you consider yourself a life-long learner? • Highly organized in keeping track of projects and clients

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Duties: • Identifies development potential in accounts by studying their current business; interviewing key customer personnel and company personnel who have worked with customer; identifying and evaluating additional needs; analyzing opportunities. • Initiates sales process by building relationships; qualifying potential; scheduling appointments. • Develops sales by making initial presentation; explaining service enhancements and additions; introducing new services. • Develops new training by preparing specifications; conferring with principles. • Closes sales by overcoming objections; preparing contracts. • Contributes information to sales strategies by evaluating current results; identifying needs to be filled; monitoring competition; analyzing and relaying customer reactions. • Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. • Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. • Maintain and updating sales funnel in Salesforce.com Compensation: Commission-based compensation only. Please do not contact job poster about other services, products or commercial interests. ************************************************************************* Eric Andrew Morse, Scientific Recruiter at R&D Partners http://bull.hn/l/REWP/1 Immediate hire for a Research Associate in South San Francisco, CA! Research Associate, Molecular Biology in South San Francisco, CA As a Research Associate, your duties will be to provide support for our Research, Development, and Clinical Laboratory. You will be working cooperatively in a busy laboratory environment, responding to change with flexibility and adapting quickly to evolving circumstances. This is an excellent opportunity for a team player to participate in the growth of a fast-paced, pioneering company that is developing systematic approaches to applying molecular diagnostics to health, disease, and medical practice. Responsibilities include: • Unpack, check and verify specimens received against accompanying requisition forms. • Follow established protocols for specimen processing, testing, and data recording. • Properly categorize and file samples into their proper storage locations. • Label, validate, accession samples and enter patient information into the Laboratory Information Management Systems (LIMS). • Provide assay support using ELISAs and multiplex technology for the Development Labs activities including: study sample analysis, assay troubleshooting, automation support, assay development, assay characterization and assay verification. • Perform scheduled maintenance on laboratory instruments and equipment. Qualifications: • B.S. degree in molecular biology, genetics, biochemistry or equivalent experience preferred.

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• Familiarity with standard molecular biology techniques strongly preferred (i.e. ELISA, RNA and DNA Preparations) • Comfortable working in a laboratory environment and able to handle specimens. • Experience with basic laboratory skills (pipetting, sample handling, etc.) required. • Experience with using Laboratory Information Management Systems (LIMS) desirable. • Ability to quickly adapt and apply new methods and technologies. • Proficiency in using basic word processing and spreadsheet applications. • Must have strong interpersonal and organization skills. • Ability to communicate clearly and effectively in writing and verbally. • Able to prioritize and drive to results with a high emphasis on quality. ******************************************************************* Posted by Leslie Miller, Experienced Operations & Administration Executive Innovation & Discovery in Biopharmaceuticals, Translational Medicine…PRINCIPAL SCIENTISTS & DRUG DISCOVERY positions at Celgene http://bit.ly/celgeneresearch …CELGENE is a global biopharmaceutical leader committed to improving patient lives and named #12 on Forbes Top 100 Most Innovative Companies. Ready to join the team and contribute to Celgene’s scientific and commercial achievements? http://www.beaker.com/Celgene_Research Research Scientist Jobs jobs.celgene.com Careers Home | Research Scientist Jobs Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. What is it that defines Celgene? Most fundamentally, Celgene is its employees, who are... -------------------------------------------------------------------------------------- Innovation & Discovery in Biopharmaceuticals…SENIOR CLINICAL SCIENTISTS & CRA positions at Celgene http://bit.ly/celgeneclinical …CELGENE is a global biopharmaceutical leader committed to improving patient lives and named #12 on Forbes Top 100 Most Innovative Companies. Ready to join the team and contribute to Celgene’s scientific and commercial achievements? http://www.beaker.com/Celgene_Clinical Clinical Jobs jobs.celgene.com Careers Home | Clinical Jobs Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. What is it that defines Celgene? Most fundamentally, Celgene is its employees, who are focused... ***************************************************** Senior QA Document Control Specialist – Full Time (San Francisco Bay Area) PPBI To view this position and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: Creates and implements all aspects of the Company’s Document Management programs and is responsible for other computer system designing and management responsibilities with respect to conformance to the regulatory and quality requirements for the manufacture of pharmaceutical and medical devices as required for Food and Drug administration (FDA) and international regulatory agency approval. Supports Pre-approval Inspection (PAI) Audits, and New Drug Application (NDA) submission Essential Duties & Responsibilities • Creates, maintains and administers Document and Change Control procedures • Creates, maintains and administers Document Control and Change Control logs and databases • Contributes as a lead to work plans for selection, validation and implementation of EDMS

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• Administers enterprise systems for document and change control • Implements file naming conventions and standards for consistent file names and file structure hierarchies. • Performs duties in support of established records management procedures, including scanning and logging records and storing records in offsite storage. • Provides support for PAI/NDA submission activities. • Establishes standards for document formatting. • Prepares document requests during regulatory inspections. • Provides document control assistance and support to the user community as required. • Reviews change control packages for correctness and completeness. • Tracks and trends outstanding Change Control and Document Control Requests. • Interacts with business partners by providing technical solutions to Document Control issues. • Conducts Document Control training. • Resolves complex Document Control issues • Prepares key performance indicator metrics EXPERIENCE AND QUALIFICATIONS: • Typically requires a minimum of eight years of related experience and/or combination of experience and education/training. • Medical device industry experience. • Very organized, prioritizes well, can handle deadlines under pressure • Works well with others and cross-functionally • Has experience with Windows 7, Office and SharePoint 2010, implementing and administering MasterControl or similar EDMS, Microsoft Access database designing. • Experience creating training materials, training groups and individuals and providing metrics on training. • Performs a diverse scope of complicated tasks. • Has wide-ranging experience in area of specialization. • Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways. • Frequently applies technical standards, principles, theories, concepts and techniques. • Applies strong analytical and business communication skills. Organizes and prioritizes numerous tasks and completes them under time constraints. • Demonstrated success in problem solving. • Ability to recognize deviation from accepted practice and to exercise judgment in resolving routine problems. • Applies strong analytical and business communication skills. • Experienced professional with a full understanding of area of specialization. • BS/BA degree in related discipline and four years of related experience; or, • MS/MA degree in related discipline and two years of related experience. To apply for a position send your resume to [email protected] Posted by Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com *************************************************** CONTACT & additional info: *** SEE www.fpccareers.com FOR FULL POSTING of this and other opportunities ***. Also, contact Ira Mann at [email protected] Validation Manager - CSV - Biopharmaceutical (permanent) - California Global Biologics leader undergoing an expansion of over 1 billion seeks a Senior Manager to lead Computer Systems Validation, Delta V and areas including the below: Top Challenges:

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1) Manage staff and provide direction in multiple computer system validation projects and drive to project completion in accordance with established timelines. Priority projects and relevant equipment include : a) New lyophilization equipment with related PLC/Allen Bradley and SCADA systems b) UF/DF & chromatography skids c) Centrifuges and filter presses d) Delta V e) Electronic Batch Records 2) Review current program against current industry standards and identify gaps. Fix gaps as needed 3) As manager of the computer systems validation, the incumbent will focus on best practices and set local policy and procedures. Incumbent will be responsible for project plans and coordination of computer system validation approaches. Develop and implement new validation approaches as needed. 4) Lead the development and execution of computer systems validation project strategies crossing Engineering, Technical Services, Manufacturing, QA/QC and Regulatory disciplines. Responsible for defining scope of work for project teams. 5) Manage, identify, hire, and develop team to support validation activities. Manage continued growth, development, and retention of the team. Location: California CONTACT & additional info: *** SEE www.fpccareers.com FOR FULL POSTING of this and other opportunities ***. Also, contact Ira Mann at [email protected] Qualifications (which should be clear on resume) : 1) 7+ years of validation experience with specific demonstrable experience in CSV 2) Delta V expertise 3) Strength in PLC, SCADA and EBR (electronic batch record). 4) 4+ years of supervisory experience including multiple cross-functional teams simultaneously. 5) BS Degree in Engineering or Computer Science 6) Experienced in project management, resource management and budgeting.

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7) Experience specific to biologics, biotechnology or biopharmaceutical industry (preferred). Key Words: CSV, computer systems validation, Delta V, EBR, electronic batch reporting, SCADA, PLC, project management, budgeting Search Jobs: Results: Validation Manager - CSV - Biopharmaceutical... fpcnational.com Global Biologics leader undergoing a large multi site expansion seeks a Senior Manager to lead Computer Systems Validation, Delta V and areas including the below: 1)Manage staff and provide direction in multiple computer system... ****************************************************** Posted by Alexander Cohen 858.427.0680, Recruiter at Simply Biotech http://bull.hn/l/REN3/5 Looking for a Quality Engineer in the Carlsbad, CA area for a Medical Device company. ISO 13485 experience required. Know anyone for this job? QUALITY ASSURANCE ENGINEER in Carlsbad, CA QUALITY ASSURANCE ENGINEER Simply Biotech specializes in recruiting exclusively for the biotech community. We are currently seeking a Quality Assurance Engineer for a leading and growing North County device firm. The qualified QA Engineer is responsible for serving as a technical resource of the Quality/Regulatory group. This position supports complaint and RMA investigations and documents all decisions appropriately. This position is also responsible for initiating the development, implementation and maintenance of policies and procedures to ensure compliance with Quality System Regulations (QSR 820) and ISO 13485, for medical devices and for performing other Quality System activities as needed to ensure quality and regulatory compliance. The Quality Assurance Engineer will also handle the following: * Continuous improvement activities to enhance the quality system, such as Lean manufacturing, Six Sigma, Cost of Quality, 5S, Kaizen, etc. * Perform Test Method Validations, Gage R&Rs, SPC. * Maintain quality metrics and trend charts. * Write Technical Documents such as Validation Protocols, Test Procedures, and Test Reports in a concise and clear manner using statistical techniques. This also includes reviewing and approving test results/product release documentation. * Support manufacturing if/when there are quality issues by performing failure analysis, and Collaborate on product and process validations. * Analyze rejects in relation to design specifications and test objectives to determine source of problem and eventually make recommendations to modify or adjust process/design to meet specifications. * Analyze reports of technical problems to determine trends affecting future design, production, service and maintenance processes and eventually recommend modifications to eliminate future problems. * Coordinate problem resolution with manufacturing, engineering, customer service and other departments. * Support Quality and Control Plans * Provide technical support to the R&D, Engineering (molding and manufacturing), Materials,

9/9/2012 16

Purchasing, and Manufacturing departments during the design phase, transfer, and production. * Support complaint and RMA investigations to determine the root cause of the problem. Work with manufacturing, R&D, and Engineering to develop an appropriate solution to any issues found. * Perform or assist in performing supplier audits, evaluations, and assessments as required. * Support the Quality Control Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system. * Understanding of the Food and Drug Administration (FDA) and ISO 13485. The Quality Assurance Engineer will possess the following qualifications: * Bachelor?s degree (BA/BS) from four-year College or university * 4+ years of related experience and/or training; or equivalent combination of education and experience. * ASQ Certified Quality Engineer (CQE) preferred. * ASQ Certified Six Sig... ******************************************************************** Biotech Manufacturing Engineer CMC Biologics A/S - San Francisco Bay Area Job Description Responsibilities:

Execution of batch operations as described in Standard Operating Procedures (SOPs) and batch execution records including, but not limited to: Cleaning, Expansion, Cell Culture, Harvest, Filtration, Purification, Formulation and Final Fill activities

Review / approval of completed batch execution records and related cGMP documentation • Assist in scheduling of Technical Operations staff to support operations activities

Perform Root Cause Analysis (RCA) in support of investigation and documentation required in a cGMP environment

Assist in project management for process and utility improvement projects Providing analytical, data management, and equipment support Troubleshooting and analysis of equipment malfunctions to assist in repair and return to

service activities Specification of equipment and process parameters Facilitation and/or execution of equipment on-boarding/commissioning activities Technical direction and training of equipment operations to colleagues Promoting a safe working environment Attainment Indicators: Standardization of processes Right First Time batch execution Development / Training of colleagues Restore Lost Function • Safe working environment Perform his/her tasks diligently and in compliance with requirements in CMC’s Quality

System Other duties as assigned

Desired Skills & Experience Requirements:

BS in Engineering or related field / equivalent experience. 8+ years engineering experience in Biotechnology Manufacturing operations,

Maintenance, Design, Process Improvement, Root Cause Analysis (RCA) Knowledgeable in the following systems: BioRx operations, Chromotography System

operations, Biopharmaceutical Filtration operations, Instrument and Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM); Pharmaceutical Utilities

9/9/2012 17

Proven expertise in planning/organization/execution of operation and maintenance activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams.

Ability to work hours necessary to support production and /or maintenance activities. Ability to lift up to 40 lbs. with assistance. Ability to work in confined spaces and near operating equipment. Ability to work in loud noise environments.

CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE For immediate consideration please email your CV to [email protected] highlighting the position in the subject line or apply directly at http://tbe.taleo.net/NA5/ats/careers/requisition.jsp?org=CMCICOS&cws=1&rid=426. Company Description CMC Biologics A/S is a contract manufacturing organization, with manufacturing facilities in Europe and the USA. The company offers a wide range of integrated cGMP manufacturing services using microbial fermentation and mammalian cell culture processes. CMC’s Copenhagen Manufacturing Facility is the first CMO in Europe who has a 2000 Liter Single-use Bioreactor . CMC's headquarters are located in Copenhagen, Denmark, part of Medicon Valley region. Its US facilities, are located in Seattle, WA and Berkeley, CA. Our Mission is to realize the potential of our customers’ biopharmaceuticals by contract process development and manufacture. Our Vision is to be a world market leader in biopharmaceutical contract services in term of quality, know-how and timeliness. Additional Information Posted: September 5, 2012 Type: Full-time Experience: Mid-Senior level Functions: Manufacturing Industries: Biotechnology Job ID: 3692573 *********************************************************************

Qualified candidates please reply to: Cindy Johnson [email protected] tel: 925-577-8135

Most Urgent Positions:

R&D Project Coordinator Staff Systems Engineer R&D Project Engineer Product Director (Marketing) R&D, MANUFACTURING & OPERATIONS ROLES

9/9/2012 18

R&D Project Coordinator

6+ years experience as a Project Coordinator (R&D support preferred) in a medical device company

Must possess strong communication skills, both written and verbal Strong attention to detail Exceptional organization skills are a must. The ability to multi-task and prioritize within multiple projects is essential. This position requires expert proficiency in Word, PowerPoint and Excel, working

knowledge of Design History File, ECO and Design Control processes.

R&D Project Engineer

BSME required, MSME preferred 3+ years experience in R&D within medical device industry Startup or small company/team experience strongly preferred Proven experience taking a project from concept to commercialization SolidWorks, catheter / implantable device experience required

Staff Systems Engineer

BSEE, advanced degree preferred A minimum of 7 years experience in embedded systems hardware development A minimum of 5 years working in the FDA compliant medical system Strong background and working knowledge of Electronics Design on embedded system

for medical applications. Mechanical knowledge for the system development a plus. Working knowledge of international standards for medical systems, including the

IEC60601 series Experience in medical device development from concept to commercialization

_______________________________________________________________________

REGULATORY, QUALITY & CLINICAL AFFAIRS

Clinical Applications Specialist ( field based)

Bachelor’s degree 10 years experience as a Clinical Applications Specialist in medical device industry Ophthalmic knowledge/experience is a strong plus Extensive travel required – 60% - 80% (must live near international airport)

Director of QA, RA (timing will be late Q4)

BSEE or BSME, advanced degree preferred 10+ years experience in leading the QA & RA functions within the medical device

industry Medical capital equipment experience required Experience working with CMO’s strongly preferred Startup experience required

_______________________________________________________________________

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SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT

Product Director, Software Products

BA, BS degree required, MBA preferred Minimum 5 years experience in marketing within medical software and capital

equipment Experience marketing medical software products is required Proven business development & product management skills are required Experience working directly with physicians and healthcare professionals on new

product and application development

Sr. Product Manager (based in Vancouver, WA)

Bachelor’s degree in business or medical field with 7-10 years Product Marketing experience. M.B.A. and/or sales experience is a plus.

Medical market experience required, ideally in pain management, orthopedic, or neuro applications and confidence in interacting with physicians, and medical technologies such as ultrasound and radio frequency.

Proven track record of adaptability and ability to extend existing and develop new relationships and marketing initiatives to make them valuable and effective in our market segment.

*********************************************************** Job Summary Date Posted: 8/9/12 Location: San Francisco, Ca, CA Job Contact Phone: 415.432.6665 Senior Corporate Counsel Medivation Job Description

Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior Corporate Counsel.

Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers.

The Senior Corporate Counsel is a new position for Medivation and will be an opportunity for the right individual who has the drive, and the desire to be on the ground floor and play a key

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role in the commercialization of new medicines, consistent with US healthcare laws and regulations.

Essential job functions include but are not limited to the following:

Responsible for providing advertising and promotion, contracting, regulatory and general legal support to the commercial and medical affairs organization. Includes daily interaction with the U.S. based brand team(s), Marketing departments, Medical Affairs and Regulatory Affairs departments, and interaction with Headquarters and other affiliates as required. May interact with government agencies, law firms, trade organizations and other external agencies.

Serves as lead counsel for one or more pharmaceutical brand(s), and includes participation in multidisciplinary committee in review of advertising, scientific and other materials

Draft, review and negotiate product-related commercial contracts, 3rd party vendor agreements, service agreements, consulting agreements and other corporate agreements

Proactively prevent or minimize legal risk to the company, and help drive legal strategy to align and achieve business strategic goals

Serve as a business partner in support of key customer group(s) with oversight and guidance by the General Counsel

Keep informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed

Requirements:

Expertise in FDA advertising and promotion regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code

J.D. with 8-15 years relevant industry and/or law firm experience A State Bar admission required Experience at a pharmaceutical or biotech company supporting marketed products Strong problem-solving and decision making skills with demonstrated ability to think

creatively and devise solutions to challenging problems Occasional travel required

******************************************************************* Beth Mackenzie Office Manager Global Recruiters of West Palm Beach (561) 422-5150 Phone (440) 425-5150 Fax [email protected] www.grnwestpalmbeach.com Marketing Research Manager # 1171 A global leader in diabetes diagnostics, offering a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics is seeking a Marketing Research Manager to develop actionable business insights, implications, and strategic recommendations from analysis of primary marketing research and other secondary and syndicated market research information Key Duties, Activities and Responsibilities:

9/9/2012 21

Create and manage internal systems for the timely and accurate collection, analysis and dissemination of information and insight derived from primary research.

Partner with internal groups to measure the market impact of marketing programs. Provide tools to marketing channels to forecast profitability of programs and to measure

actual profitability after the programs have executed. Develop recommendations based on these analyses for future marketing efforts.

Provide inputs to annual planning process and manage monthly reporting processes on market conditions, competitive performance, and explanation of drivers of observed market conditions.

Develop and manage relationships with key vendors and suppliers. Build and develop high performing Marketing research team. Develop annual budget for Marketing Research and track performance against that

budget monthly. Negotiate for necessary funding and cross-functional resource needs. Research and recommend additional syndicated market research purchases to drive

increased understanding of the business and opportunities to drive competitive differentiation and business growth.

Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.

Serve as marketing research expert related to customer needs, market conditions, competitive activity.

Accountable for providing actionable business insights implications, and strategic recommendations from analysis of primary, secondary and syndicated market research information.

Work Experience, Skills and Education Required:

8 years (or 6 years with MBA) combined sales, marketing or marketing research. Previous healthcare experience preferred. Exceptional analytical, mathematical and problem solving skills Excellent oral and written communication skills (including presentation and listening

skills) High energy level and positive attitude; confidence Integrity and professionalism Initiative and self-motivation; strong work ethic Career ambition Organizational skills and attention to detail Leadership and team orientation; ability to work with others; ability to work in a

matrixed environment Bachelor's degree required; MBA preferred

________________________________________________________________ Director of Marketing - Automation, CA # 1114 A major global pharmaceutical, biotech and diagnostics company is searching for a Sr. Product Marketing Manager Core Products. The incumbent will assist with development of comprehensive marketing plans for new and on-market products in the company’s Core Products portfolio. Key Duties, Activities and Responsibilities: · Assess customer needs, competitive risks, and long-term market potential. · Outline successful marketing strategies that include activities to support full portfolio of

instrumentation, assays and reference lab services. · Identify and resolve specific business issues and opportunities that arise.

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· Market expertise in the Core Products market, understand what factors influence and shape the market including: growth trends, industry and competitive analysis, environmental conditions, technologies, and capabilities.

· Sales support – Effectively translate market strategy into support for sales objectives. · Customer focus – Identify opportunities and threats in the marketplace by attending trade

shows and symposiums, and interfacing with customers and KOLs. Work Experience, Skills and Education Required: · Bachelors of Science and/or Masters in Business Administration · 6+ years experience in diagnostics marketing or sales. · Blood banking or infections disease testing/instrumentation experience highly desirable · Laboratory experience preferred · Technical background in Core Products strongly preferred · Data analysis and writing market development plans a plus · Ability to manage agencies, suppliers and budgets. · Ability to manage project teams and projects within deadlines · Ability to take direction well and follow-through on projects · Ability to work on multiple projects simultaneously · Strong written and oral communication skills. · Ability to work well within a team as well as independently. Strong strategic skills. ____________________________________________________ Marketing Manager, CA # 1110 A major global pharmaceutical, biotech and diagnostics company is searching for a Marketing Manager. Responsible for Product Marketing and certain Diagnostics regional external customer and internal communication, including market communications, product launches, communication plans, and congresses/events. Key Duties, Activities and Responsibilities: · Assist with development of key customer business plans and of Marketing Plan for Blood

Screening and Blood Typing products. · Develop current and relevant sales tools and training of sales force · Monitor competitive tactics and strategies, conduct regular competitive reviews and

communicate throughout AMERICAS Team · Assist in analysis of market trends through customer contact, attendance at scientific and

appropriate blood bank meetings · Work with the Americas Commercial team to execute all logistics associated with marketing

events, scientific, media, advisory board meetings, congresses and customer meetings throughout the Americas

· Region while adhering to all SOPs regarding compliance and timeliness of review · Develop and implement product lifecycle for the Americas region – regulatory, scientific,

customer service, quality, supply chain. · Develop monthly forecast; conduct analysis and monitor business results against budget and

plan; develop proposals for new products and product improvements · Work with regional marketing managers and global marketing and communications team to

develop, coordinate, and execute country-specific communication plans · Liaise with Global Marketing and Communications functions to ensure consistent message in

all forums (print, congress, interviews) · Ensure consistency of Novartis brand and market position in external communications, by

ensuring alignment at all levels. · Participate in the development or modification of marketing collateral to be used in the

AMERICAS market to promote the sale of Diagnostic Division products

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· Implement Sponsorship and Marketing expenses, track and process all associated budgets and expenditures..

Work Experience, Skills and Education Required: · BS in life science or marketing and/or MBA highly preferred Emphasis in liberal studies,

English, communications, public relations, or journalism preferred · 5 years marketing experience with 3-6 years experience in sales and marketing organization

in diagnostics/medical devices, with emphasis on product development and project management required

· Experience in communications positions, including high-level involvement in marketing communications, media and Key Opinion Leader relations

· Strong written, verbal, and interpersonal communication skills. · Excellent attention to details and detailed planning. · Ability to work independently, as well as in close collaboration is required. · English is mandatory; other languages including but not limited to Spanish, Portuguese,

French preferred ______________________________________________ Hospital Service Representative NW Region (CA) # 1190 A leading global healthcare technology company that manufactures and distributes diagnostics / medical devices products and services is looking for a Hospital Service Representative to hire, lead, coach, train and develop the Hospital Service Team and assist Hospital Account Managers as they service customers as well. Responsible to develop retention strategies for assigned area which ensure profitable growth aligned with all company business objectives, and high levels of customer satisfaction. This will include Hospital Service Rep lead generation accountability, supporting marketing and sales initiatives and collaboration between service and sales. Key Duties, Activities and Responsibilities: •Develop service plans for retention and expanding existing accounts. Ensure the implementation of national and regional service plans and strategies. Ensure team meets retention targets by growing profitable base business and generating client loyalty. •Partner with the Hospital Sales Director and the Business Unit and operations to develop overall business unit plans for increasing profitability of the existing business through targeted plans and execution of national strategies and initiatives. •Lead the service team in developing account-specific strategies to profitably grow and maintain the business. Provides guidance to team members to ensure successful implementation of service plans and developing approaches to minimizing/handling obstacles. •Implement account management, pricing and marketing initiatives. Manage all service processes such as pricing and service changes to ensure customer's needs and business objectives are satisfied. •Ensure service team adheres to all Compliance programs and government regulations. •Ensure that budget expectations are met, including applicable lead generation and retention forecasts. •Responsible for working within all company testing sites, developing relationships internally with the operations team, attending service meetings, market strategy meetings (as required) and communicating strategies. •Facilitating conference calls or meetings with key operations staff to address service problems with the service team identifying service trends and potential resolutions. Communicate those solutions back to customer for resolution. •Serve as consultant to Hospital Sales Director on key strategy and service management issues. •Manage all administrative and reporting tasks for position including managing special projects or initiatives as assigned by the Hospital Sales Director.

9/9/2012 24

•Responsible for the recruitment, selection, retention, and motivation of the service team including training, development, and performance management. Qualifications Work Experience, Skills and Education Required: •Bachelor's degree in a Business, Marketing or the Life Sciences •At least five years of successful direct outside sales and service in a healthcare field. •Prefer at least three years of supervisory experience within the healthcare industry with proven ability to direct and influence others to achieve common goals •Demonstrated ability to operate successfully in a complex organization structure •Ability to develop and sustain strong customer relationships. •In-depth knowledge of sales management, market strategy and the healthcare industry •Excellent quantitative analysis skills •Excellent Microsoft Office and other computer skills •Must have strong collaborative Communication skills •Solid verbal and written presentation skills •Strong planning and organizational skills •Per week, at least 3 consecutive days of travel working in the field is required, requiring overnight stays. ____________________________________________________________ Market Development Manager # 1200 A molecular diagnostics company committed to providing safe, highly accurate and affordable prenatal tests for maternal and fetal health is seeking a Market Development Manager to be responsible for developing and executing sales strategies for large business development opportunities such as Integrated Delivery Network (IDN) and Independent Practice Association (IPA) clients that include hospital affiliates, medical clinics and group practices. This sales professional will be responsible for securing contracts with IDN and IPA clients and for these clients, meeting or exceeding established program sales goals and market share targets within a given geographical territory; and will introduce a new clinical technology to providers, individual hospitals, and maternal care centers in the women’s health community, with a critical focus on increasing prenatal test adoption in the defined market. Key Duties, Activities and Responsibilities: · Working with the commercial management team to identify IDN and IPA client opportunities · Develop and implement territory sales strategies, detailing, competitive differentiation,

presentation, closing, implementation and post-adoption follow up. · Utilize effective sales techniques in order to gain access to decision makers and influence

purchasing decisions. · Apply strong interpersonal skills to establish relationships of trust that allow for directed

probing to uncover the IDN and IPA client needs and develop solutions within the company framework that meet these needs.

· Build IDN/IPA alliances, establish and maintain product market leadership, and achieve long and short-term sales objectives by providing solutions and creating relationships between the Company and IDN/IPA clients.

· Engage co-marketing partners of the Company and create productive relationships with sales executives of those partners.

· Consistently meet established territory sales goals by targeted call points. · Utilize CRM database to document territory management activities, including pre-call planning

and call reports, as well as to document competitive intelligence. · Prepare territory plans as required. · Interact with all levels of the health systems and care delivery organizations or other

assigned targets/clients on a regular basis.

9/9/2012 25

· Participate in, and travel to, tradeshows and other medical education/outreach events, as needed.

Work Experience, Skills and Education Required: · We seek a proven individual with a successful track record in complex health care sales

environments, preferably with a background in both healthcare systems selling and provider selling.

· Previous experience: 5+ years of progressively responsible sales experience with IDN and IPA clients

· Experience with prenatal diagnostics and/or capital equipment in a hospital system setting strongly preferred

· Education: Bachelor’s Degree or higher · A team player and superior interpersonal skills · A strong track record of sales performance · Ideal candidate will have existing or past history of relationships in the geography with

medical centers, hospitals and health systems and proven ability to successfully navigate and manage a multi-tiered sale

· Must possess a strong scientific and clinical/business acumen · Strong sales skills and presentation skills are required, including written and verbal

presentations · Thinking, planning, and superior organization skills to effectively manage multiple priorities in

a fast paced environment · Basic business skills (budgeting, forecasting, trend analysis) · 50% travel required ___________________________________________________________________ Hospital Account Executive – CA #1123 A leader in diagnostic laboratory testing, information, and services seeks a Hospital Account Executive located in California. To target and secure profitable new business in assigned hospital accounts by building relationships and aligning with regional and national marketing strategies. Key Duties, Activities and Responsibilities: • Target and secure profitable new business in line with regional marketing strategy by

effectively targeting prospective accounts, creating in-depth prospect profiles, building relationships and securing the business.

• Provide overall support and expertise to new accounts to ensure clients receive highest level of quality service utilizing operational personnel to resolve problems and when necessary.

• Participate with local leadership in developing overall business unit plans for increasing volume and profitability through implementation and execution of national strategies and initiatives.

• Prepare and present proposals and bids by using all standard processes, procedures and templates.

• Perform any other tasks as assigned by the manager. • Essential Expectations:

• 80% of New Sales Budget • Proper utilization of Technology Enabled Selling (TES) tool • Proper utilization of Strategic Account Executive

Work Experience, Skills and Education Required: • Bachelor’s degree in Business, Marketing or the Life Sciences; • At least five years of successful AND PROVEN front line sales experience including strong

“closing” skills • Ability to develop and sustain strong customer relationships

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• Strong planning and organizational skills • Excellent oral and written communication and presentation skills • Solid PC skills including working knowledge of Microsoft Software • Knowledge of the healthcare industry • Experience selling products/services into the hospital laboratory is required ___________________________________________________________________________

_____ Hospital Service Manager SW Region (CA) # 1191 A leading global healthcare technology company that manufactures and distributes diagnostics / medical devices products and services is looking for a Hospital Service Manager to hire, lead, coach, train and develop the Hospital Service Team and assist Hospital Account Managers as they service customers as well. Responsible to develop retention strategies for assigned area which ensure profitable growth aligned with all company business objectives, and high levels of customer satisfaction. This will include Hospital Service Rep lead generation accountability, supporting marketing and sales initiatives and collaboration between service and sales. Key Duties, Activities and Responsibilities: •Develop service plans for retention and expanding existing accounts. Ensure the implementation of national and regional service plans and strategies. Ensure team meets retention targets by growing profitable base business and generating client loyalty. •Partner with the Hospital Sales Director and the Business Unit and operations to develop overall business unit plans for increasing profitability of the existing business through targeted plans and execution of national strategies and initiatives. •Lead the service team in developing account-specific strategies to profitably grow and maintain the business. Provides guidance to team members to ensure successful implementation of service plans and developing approaches to minimizing/handling obstacles. •Implement account management, pricing and marketing initiatives. Manage all service processes such as pricing and service changes to ensure customer's needs and business objectives are satisfied. •Ensure service team adheres to all Compliance programs and government regulations. •Ensure that budget expectations are met, including applicable lead generation and retention forecasts. •Responsible for working within all company testing sites, developing relationships internally with the operations team, attending service meetings, market strategy meetings (as required) and communicating strategies. •Facilitating conference calls or meetings with key operations staff to address service problems with the service team identifying service trends and potential resolutions. Communicate those solutions back to customer for resolution. •Serve as consultant to Hospital Sales Director on key strategy and service management issues. •Manage all administrative and reporting tasks for position including managing special projects or initiatives as assigned by the Hospital Sales Director. •Responsible for the recruitment, selection, retention, and motivation of the service team including training, development, and performance management. Qualifications Work Experience, Skills and Education Required: •Bachelor's degree in a Business, Marketing or the Life Sciences •At least five years of successful direct outside sales and service in a healthcare field. •Prefer at least three years of supervisory experience within the healthcare industry with proven ability to direct and influence others to achieve common goals •Demonstrated ability to operate successfully in a complex organization structure •Ability to develop and sustain strong customer relationships.

9/9/2012 27

•In-depth knowledge of sales management, market strategy and the healthcare industry •Excellent quantitative analysis skills •Excellent Microsoft Office and other computer skills •Must have strong collaborative Communication skills •Solid verbal and written presentation skills •Strong planning and organizational skills •Per week, at least 3 consecutive days of travel working in the field is required, requiring overnight stays. ________________________________________________________________ Senior Director, Business Development– CA # 1037 A leading diagnostics and laboratory services organization that provides products and services in the hematology, oncology and other specialties arenas is seeking a Senior Director, Business Development. Key Duties, Activities and Responsibilities: · The successful candidate will participate in identifying new products for in licensing or

acquisition to offer in our Company clinical lab. · This will include generating preliminary Market models, Technical assessment reports and

financial projections for these opportunities. · The candidate will work closely with Marketing, Finance, Legal, IP, Regulatory and

Compliance in due diligence and generation of contracts and licensing agreements for potential products.

· There will also be close cooperation with our counterparts in cities and interactions with several divisions of Pharma and Business within the Company.

Work Experience, Skills and Education Required: · A strong work ethic and ability to lead multidisciplinary teams · A combination of PhD (preferably in a biological discipline) and MBA is most desired · At least 5 years experience in business development, financial modeling, or quantitative

marketing · A track record demonstrating strong analytic skills in market assessment, valuation, IP

analysis, and technical analysis · Familiarity with use of business and financial databases, and analytic methods · Strong communicative skills with ability to rapidly generate MS Excel and PowerPoint based

presentations and to present them effectively to Sr. Management. · Ability to generate accurate and timely budge · Demonstrated strong personnel management skills · Experience in diagnostics · Knowledge of CPT and disease coding · Familiarity with Laboratory, Marketing and Sales organizations · Familiarity with Pharma organizations ************************************************ ***************************************************** Scott Bailey Senior Partner Ocean Medical, Inc. EXPERIENCE. MEANS. OPPORTUNITY. (904) 237-2407 [email protected]

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Skype: scottbailey8 Director Engineering and a Director New Product Introduction for a global, US-based medical device company. This Corporate and US Manufacturing site (Franchise Headquarters), along with overseas manufacturing, has created two new roles:

- Director Engineering (Director Franchise Operations Development Engineering and Process Capability)

- Director NPI (Director New Product Introduction Operations Readiness and Integration) These critical and highly visible roles take into account many aspects of career development, including succession planning, and report into the Worldwide VP Franchise Operations. Working with the highest levels of the Corporation and interaction with the Global Management Board, these Strategic Leaders will cover New Product Introduction Engineering and New Product Introduction Operations capabilities including: Director Engineering: develop new and improve current product process capabilities for overall business growth. This Technical Professional will mentor, lead, and guide the efforts of Fellows, Managers, Senior Managers, and Directors in all stages of new product introduction including process development engineering, design transfer, hi-speed automated equipment capabilities (engineering, installing, validating, debugging, and optimizing), and packaging for final global product launch. Director NPI: entrusted with the stewardship and accountability for the Supply Chain, and all new product introductions and launches within the Franchise. This Development and Operational Professional will mentor, lead, and guide a team of PhD level Analysts, Project Leaders, and Managers that oversee all aspects of cost-efficient technology transfer, global launch, and supply sustainability within the Franchise product portfolio. This will include the integration of all product introduction activities to ensure that all aspects of bringing a new product to commercialization are addressed within the Supply Chain (supplier qualifications, Supply Chain readiness, site selection), and technology transfer through global product launch, from napkin sketch concept to full and long term scale-up production. For both roles, demonstrated professional strengths in communication, leadership, coordination, collaboration, partnering, global thinking, strategic thinking, project management, process orientation, and succession planning are essential. Your current title is likely to be Director R&D, Director Operations, Director Engineering, Director Process Engineering, Director (Equipment) Product Development, Director New Product Introduction and Supply Chain, Senior Director, or VP. Your product experience with hi-speed, automated, capital equipment and associated medical device disposables (perhaps monomer, polymer, silicon, rubber, or packaging) would be considered a valuable asset to the company. ******************************************************

Jobs That Crossed My Desk Through Sept. 5, 2012 ********************************************************** Apply on company website

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VP, Safety Science Oncology Therapeutic Head Genentech - South San Francisco, CA (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Job Purpose: The Head, Safety Sciences, leads and directs one of the therapeutic areas of safety science aligned with the Oncology disease to provide strategic direction and standardization of performance across the Safety Science groups. The Head, Safety Sciences directs Product Development Safety's (PDS) disease area specific scientific analysis including medical evaluation, risk assessment and management, signal prediction/detection, Comparative Benefit Risk, using epidemiology and other input as appropriate. The Head, Safety Sciences will ensure the incorporation of Comparative Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the cluster to ensure their longevity. In general, he/she is a member of a Development Review Committee (DRC). Primary Responsibilities: � Ensure proactive surveillance and monitoring activities across their safety science cluster to ensure that Roche is aware of potential emerging safety issues and has developed strategies & action plans to prevent & mitigate risks. � Direct and manage the SSLs and their teams within the safety science therapeutic area and provide guidance to the relevant development and safety committees as appropriate. � Maintain managerial oversight of issues and outputs from the therapeutic area Safety Teams address or elevate issues to the PDS Global Head, Drug Safety Committee, Lifecycle Teams, Research and Early Development teams, and various committees. � Ensure the incorporation of Comparative Benefit-Risk concepts & qualitative/quantitative methods in the Disease Area (in collaboration with Clinical, Regulatory & Medical Affairs) and their use throughout the development and commercial lifecycle to ensure the safety and longevity of all products in their therapeutic area. � Lead continuous improvement efforts in Safety Science capability and performance together with the other Heads of Safety Science areas. Provide leadership and line management to their reports and other members of the Safety Sciences department across multiple locations. � Build and leverage Roche and PDS’ influence with internal and external entities to create value for Roche. � Ensure Collaborative and constructive business relationships with major partners where applicable (with particular interest in Chugai). Ensure particular emphasis is placed on communication flow and inter company. � Contributes as part of the Global Leadership Team to the overall management of the Safety Risk Management Department. � Partners with Clinical Development organization to facilitate and collaborate towards the development of new oncology products proactively. Build strategic relationships with Clinical Development Oncology to drive innovative trial designs and influence decision-making.

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Who You Are Education/Qualifications: Minimum: � MD with a specialty (Internal Medicine, Pediatrics, Geriatrics, or other relevant to the disease are specialty). An additional degree (e.g. PhD, MBA, MSc, MPH) is a plus, � 5 years clinical practice required � 3-5 years pharmaceutical/biotech industry clinical drug development experience desired Experience, Skills, Knowledge � Significant clinical experience in treating patients and significant experience in pharmaceutical industry (clinical development, drug safety, medical affairs) � Previous experience at a management level in drug safety, clinical development or medical affairs, including in the evaluation and interpretation of scientific and clinical data. Credible knowledge of Safety Science across a breadth of therapeutic areas. � Demonstrated experience of managing global pharmacovigilance activities, particularly in relation to issue management and signal prediction, detection and evaluation. � Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations � Solid knowledge of Asian pharmacovigilance regulatory requirements and general regulatory expectations is a plus � Proven experience in managing a team of individuals located across a number of sites and in leading them to optimize their performance and contribution. Proven ability to coach and develop people � Strong negotiation skills � Strong written and verbal communication skills to a variety of levels and teams. Demonstrated persuasion and influence skills � Ability to operate objectively and independently as a leader and as a member of a team, as required � Proven ability to manage budget and timelines � Ability to interact with high level officials in Health Authorities and other policy makers � Willingness to undertake significant travel internationally � Ability to work effectively across cultures and in virtual environment Additional Information: � The Head, Safety Science Oncology could be a member of the Drug Safety Committee. � Associate Safety Science Oncology Heads will report into this role from various sites. � When necessary, the Head of a Safety Science may also be the site Head for all Safety Science staff on the site Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply Additional Information Posted: August 21, 2012 Type: Full-time Experience: Executive Functions: Other Industries: Biotechnology, Pharmaceuticals Employer Job ID: 00384462 Job ID: 3456026

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************************************************************ Apply on company website Senior Market Research Manager Actelion - South San Francisco (San Francisco Bay Area) Job Description POSITION SUMMARY The Senior Market Research Manager will lead the market planning and market research strategies for all marketed brands in the US, with a particular focus on the Pulmonary Arterial Hypertension (PAH) portfolio, in order to facilitate the successful execution of Actelion Pharmaceuticals U.S. commercial objectives. The Sr. Manager will execute high quality studies that generate actionable business insights and support strategic decision making for the brands. This position is responsible for all local level market research studies and will collaborate with the Global team for Global market research studies. PRIMARY RESPONSIBILITIES include the following. Other duties may be assigned

Engage internal departments to understand market research needs and conduct quantitative and qualitative market research aimed at such topics as patient flow, Attitude, Trial, and Usage (ATU) tracking, positioning, message recall, segmentation and perceptual mapping.

Leverage product and market knowledge to understand key business questions and issues and to design and execute high quality studies.

Develop ad hoc projects as needed to test appropriate market variables. Collaborate cross functionally to ensure best outcome to research projects. Construct and present findings from market research to brand teams and senior

management as actionable business insights. Support strategic decision making through incorporation of marketplace information

into business plans and forecasting. Interface with our Global counterparts to ensure alignment in activities, methodology,

and insights. Select, train, and manage market research vendors.

Desired Skills & Experience BA/BS/MS/MA in an analytical field with a strong academic record or equivalent. Minimum of 5 years of pharmaceutical or analytical consulting work experience with

exposure to both primary and secondary market research methods Expertise in data management tools (e.g., Excel) as well as Word and PowerPoint. Experience analyzing secondary data in the pharmaceutical industry (IMS, WK) a plus. Adept at summarizing analytical information and translating it into simple language Must be skilled at multi-tasking, problem solving, project management and working in a

fast environment Able to prepare and present clear and concise reports Communication skills should allow candidate to succinctly and accurately present top-

line conclusions from market research to all types of audiences Great relationship-building abilities and ability to work cross-functionally

Actelion provides equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability and all other protected categories. EEO Company Description Actelion Pharmaceuticals Ltd is a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, focusing on the discovery, development and commercialization of innovative treatments to serve high unmet medical needs. Actelion was founded on 17 December 1997 and is now a public listed company on the Swiss stock exchange (SIX).

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Additional Information Posted: August 8, 2012 Type: Full-time Experience: Mid-Senior level Functions: Other Industries: Pharmaceuticals Job ID: 3364166 **************************************************** Contact If interested, please email Jennifer Holt at [email protected]. Senior Manager, Medical Writing, Foster City, CA Location: San Francisco Bay Area The Medical Writing function resides organizationally within within Regulatory Affairs, and provides scientific/regulatory writing services to support clinical trial reporting as well as a wide variety of regulatory submissions across antiviral, respiratory, cardiovascular, and oncology indications. This position is responsible for working with project teams across sites to produce complex clinical documents for global regulatory submissions, including clinical summaries and overviews, clinical study reports (CSRs), investigator brochures, pediatric investigational plans (PIPs), clinical trial results postings (ClinicalTrials.gov), and other key clinical and regulatory documents.

Is able to prepare a wide variety of regulatory documents independently or with minimal supervision

Writes multi-study summary documents for pivotal studies Writes sections of product approval applications and other submissions Works with Biometrics on clinical data interpretation Reviews and prepares FDA briefing packages Serves as a cross-functional resource Can facilitate issue resolution and lead multi-functional teams with clear direction

through complex processes Essential Duties and Job Functions Demonstrated ability to prepare a wide range of regulatory documents, such as clinical study reports and Investigator Brochures, as well as CTD summaries, pediatric investigational plans [PIPs], and regulatory responses, in-line with regulatory requirements and internal document standards, and without appreciable supervision

Contributes to other non-regulatory medical writing activities as required. Participates in submission teams and provides advice/guidance for optimal presentation

of data for achievement of document objectives. Leads document timeline/resource planning for assigned projects within the submission

team. Works collaboratively with functional contributors (clinical, biometrics, virology etc),

ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines.

Performance management may be required. Leads the compilation of final documents and appendices coordinating clinical,

biometrics and regulatory contributions. Leads/contributes to development work in relation to document standards, continuing

MS template development, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing.

Demonstrated success in the independent preparation of regulatory documents, particularly at the individual study report level.

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Excellent verbal communication skills. Knowledgeable of regulatory document requirements/guidelines. Well developed computer skills including proficiency in Word, Adobe and Excel

Knowledge, Experience, and Skills

Typically requires a BS degree and minimum 10 years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology which includes 5+ years of relevant experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.

10+ years of experience with a BA degree. 8+ years of experience with an MS degree. 4+ years of experience with PhD, MD or DVM. 5+ years in medical writing or the clinical submissions environment preparing

documents for regulatory submissions.

********************************************************** Contact For consideration please submit your resume to http://www.perkinelmer.com/ourcompany/careers/careeropportunities/default.xhtml If you know of someone who would be a good fit for the positions listed below, feel free to forward them this information. Olga Campa, SPHR | Human Resources Senior HR Manager/HR Business Partner Caliper - a PerkinElmer Company | Life Sciences & Technology 2061 Challenger Drive | Alameda | CA 94501 | United States Office: 510-291-6155 [email protected] Caliper, a PerkinElmer company is a leading provider of cutting-edge technologies enabling researchers in the life sciences to create life-saving and enhancing medicines and diagnostic tests more quickly and efficiently. Caliper has compiled numerous best-in-class solutions and is aggressively innovating new technologies to bridge the gaps that exist in bringing in vitro assays to in vivo results and ultimately into cures for human disease. With a keen focus on clinically-relevant experimentation, Caliper’s portfolio of offerings includes state-of-the-art microfluidics, lab automation & liquid handling, optical imaging technologies, and discovery & development outsourcing solutions. Our company represents a community of intelligent, highly-motivated people dedicated to working together as a team to improve the human condition through innovation in life sciences research. Caliper’s customers and partners include leading pharmaceutical companies like Pfizer, GlaxoSmithKline, Sanofi-Aventis, Novartis, and AstraZeneca, among others. If you are committed to making a significant difference worldwide, we invite you to learn more about the amazing opportunities that await you at PerkinElmer. Senior Scientist (#4233): Alameda, CA We are recruiting for the following regular full-time job opportunity as a Senior Scientist. If you would like to learn more about this position, please see our PerkinElmer Careers Page, search for North America, then Senior Scientist (Job Code 4233). All applicants must apply online for consideration.

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Our LST group is seeking a Senior Scientist to support sustaining activities for systems development of new imaging platforms and instrument sales for our in vivo entity under LST at the Alameda site while providing a bridge between the transitions of probes from preclinical to clinical use by performing critical experiments to define future instrument specifications. Responsibilities: • Animal modeling studies with bioluminescent, fluorescent and CT readouts in a longitudinal format. • Design of experiments that are hypothesis and biomarker pathway driven for preclinical and PK/PD studies. • Conception and implementation of customer driven study designs that use different imaging modalities in oncology, infectious, CNS and cardiovascular disease states. • Cross functional interactions with engineering, physics and software teams to support hardware and software development. Qualifications: • PhD in cell molecular biology, pharmacology, or biochemistry with 2-5y post-graduation • Proficient in optical imaging techniques, familiarity with other imaging modalities such as ultrasonic imaging, PET/CT and MRI. • Comprehensive skills in cellular, molecular biology and pharmacology pertaining to small animal experimental techniques, vector construction, gene transfer and expression, DNA/RNA and protein analysis, cell and tissue culture, transfection, in vitro and in vivo drug toxicity and effect, handling in small animals with different tumor types, infectious agents QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential of the above listed essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE PhD in cell molecular biology, pharmacology, or biochemistry with 2-5y post-graduation REASONING ABILITY Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism [formulas, scientific equations, graphs, etc. in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and color vision. *************************************************************************************

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For consideration or to learn more information about this position and other career opportunities, go to http://www.perkinelmer.com/ourcompany/careers/careeropportunities/default.xhtml About Us As a global technology leader, PerkinElmer is taking action to harness the power of insights and transform them into knowledge to deliver innovative, differentiated solutions for our customers. From critical therapeutic and disease research and prenatal screening, to environmental testing and industrial monitoring, we are actively engaged in improving health and advancing quality and longevity of life all around the world. From multi-vendor laboratory services, software and informatics, to clinical lab testing and unparalleled customer care; we have the people, tools and resources to help customers solve their business and scientific goals. Our core competencies, coupled with our commitment to excellence, provide a strong foundation for delivering optimal service and support. By encouraging exploration, ingenuity and integrity, together with teamwork and employee development, at PerkinElmer we live our mission, every day. If you have an interest in becoming a part of a fast growing, innovative company and possess the skills to excel in the position posted, please submit your resume at http://www.perkinelmer.com/ourcompany/careers/careeropportunities/default.xhtml. To learn more about this or other career opportunities and/or to learn more about the possibilities with PerkinElmer go to: www.perkinelmer.com. If you have an interest in becoming a part of a fast growing innovative company and possess the skills to excel in the position apply today! ***************************************************** Tricia Gamble Tel. 323.399.5570 Process Engineer I am contacting you from Pharma-Bio Serv. Our company currently provides cGMP compliance, validation, computer services, technology transfer, safety, environmental and training services to the pharmaceutical, medical device and biotechnology industries. We are currently looking to fill within the Process Engineer arena. The client is located in Vacaville, CA and is looking for a Process Engineer with Transdermal Systems experience ASAP. If you are interested and are currently available or in search of a new opportunity, please give me a call at my number listed below. I can be reached between 7:00 AM – 7:00 PM PST ********************************************************

For immediate consideration, please apply directly at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Cleaning-Validation-Gap-Assessment-Consultant-Southern-CA/2e16279e/?source=social-linkedin-group-jobs

Cleaning Validation Gap Assessment Consultant - Southern, CA

Now hiring: Cleaning Validation Gap Assessment Consultant - Southern, CA.

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*************************************************** Apply on company website Sr. Regulatory Affairs Analyst/Manager Sterling Life Sciences - California (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/RegulatoryAffairs-Job-Biotechnology-California-17420 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Create regulatory strategy for new products 2) Manage filing related activities 3) Provide regulatory expertise on daily issues and interface with outside regulatory agencies 4) Manage assigned product registration activities, including filing determinations, 510ks, technical files and international product registrations 5) Compile information from multiple sources for submissions, guiding the project teams in creating documentation for submissions, writing summaries and other required documentation for submissions 6) Prepare annual licensing renewal, product registration and listings 7) Establish quality system related procedures and policies for regulatory affairs and update as necessary 8) Provide guidance in complying with regulations 9) Assist in developing rationale and documentation for new product development, product changes, testing, design review, labeling changes, packaging changes, material changes, etc. 10) Review and approve product labeling and promotional materials in accordance with global regulations 11) Represent regulatory affairs on project teams 12) Attend product project teams meetings, as required and provide regulatory guidance and review 13) Review and approve document change orders 14) Assist the product safety team with making product safety determinations

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15) Conduct Medical Device Reporting (MDR), vigilance activities, product corrections and removals in a timely manner 16) Develop regulatory strategies, templates and documentation for product registrations for each new or modified product 17) Interface with FDA on regulatory issues and international regulatory agencies 18) Assist management in planning regulatory activities 19) Identify road blocks, strategizing on various regulatory paths for new products 20) Work with Quality, Engineering, and Marketing to ensure product supply 21) Interface with customs officials to resolve product holds TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 30, 2012 Type: Full-time Experience: Mid-Senior level Functions: Science, Project Management, Quality Assurance Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 17420

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Job ID: 3657538 _______________________________________________ Vice President of International Sales Sterling Life Sciences - California- South Region (Orange County, California Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-Job-Biotechnology-California-SouthRegion-17354 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Develop key relationships with international customers 2) Work closely with the Project, Design, Marketing and Production teams to ensure customer requirements are met on a timely basis 3) Achieve pre-defined sales targets TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials.

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Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 29, 2012 Type: Full-time Experience: Executive Functions: Sales, Business Development, Marketing Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 17354 Job ID: 3649538 ______________________________________________ President Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/GeneralManagement-Job-Biotechnology-California-SouthRegion-17352 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Provide leadership to the profession, the board and the membership 2) Act as the main liaison between the Board and the Executive Director 3) Initiate and lead the board's process of annual performance review of the executive director in consultation with the Vice-President 4) Plan and chair Board and general meetings, including meeting agenda preparation in consultation with the executive director TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at:

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http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 29, 2012 Type: Full-time Experience: Executive Functions: Management Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 17352 Job ID: 3649536 **************************************************** Apply at company website at www.glumetrics.com/ Clinical System Verification Engineer Glumetrics, Inc. - Orange County, California Area Job Description Design, perform, and maintain software test protocols. Work with software engineers to understand requirements and design specifications. Design and execute appropriate test protocols for design verification and validation. Trouble-shoot monitor problems at U.S. and international clinical study sites with Clinical Research Associates (CRAs). Technical liaison between CRAs and Engineering.

Design verification and validation test protocols from software requirements and design documentation.

Execute test protocols, keep accurate and detailed test logs, and generate test reports. Analyze reported monitor and related problems from the field, clinical or other sources.

Assist in finding root causes. Maintain and update requirements tracing, issue tracking, and other development

processes. Work with Clinical Research Associates to integrate clinical protocols and checklists with

current state of monitor functionality. Train CRAs on new monitor functionality as it is developed by engineering. Available to travel on short notice to U.S. and international clinical study sites and

trouble-shoot monitor problems with CRAs on site. Assume role of lead technical person in animal studies.

Competencies: Analytical, Design, Temperament, Adaptability, Dependability, Innovation No relocation provided. Must be able to interview in person at the Irvine, CA office. Unsolicited resumes from recruiters will not be considered. Desired Skills & Experience

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Bachelor’s degree (B.S.) or equivalent in a scientific or engineering discipline, and two to five years related experience and/or training; or equivalent combination of education and experience. Field engineer experience is a plus.

2+ years software test experience in industry Prefer knowledge of medical devices and FDA regulatory path and standards Must have solid hands-on test and debug experience Some software programming experience is preferable Experience with digital hardware designs and A/D designs and interfaces is preferable,

but not required. Understanding and knowledge of optical communications channels is preferable Excellent English written and verbal communication skills Desire and ability to work in a small team environment Occasional exposure to hospital and laboratory environments requiring universal

precautions Computer Skills: To perform this job successfully, an individual should have knowledge of Microsoft Office products including Word, Excel, PowerPoint and Outlook, and Internet. Knowledge of software development tools, requirements management tools and defect tracking tools is a plus. Knowledge of at least one database development software is a plus (such as Microsoft Access). Ability to write simple software routines is a plus. Company Description GluMetrics is developing the GluCath® intravascular continuous glucose monitor* to accurately, conveniently and continuously measure blood sugar. The system is designed to address the challenging needs of the intensive care environment. Clinical studies are in process with initial data having been presented at major medical meetings including ADA, EASD, ASA and ISICEM. *CAUTION–Investigational Device. Limited by United States law to investigational use. In addition to a fantastic salary based on experience, we offer:

Healthcare plan 401k plan Paid holidays Long-term and short-term disability Life insurance Variety of voluntary benefits

We work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture. Additional Information Posted: August 30, 2012 Type: Full-time Experience: Associate Functions: Quality Assurance, Engineering, Other Industries: Medical Devices Compensation: $120k-140k, DOE Job ID: 3662414 ******************************************* CONTACT: Janet Jarboe, Principal FOR JOB DESCRIPTIONS Jarboe & Associates [email protected] 970-686-5899 (OFFICE) 970-689-2962 (MOBILE) SERVING PROFESSIONALS SINCE 1997 - CONFIDENTIAL SERVICES

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Associate Director/ Director, Program Management - CA 1. 8+ years’ experience as a cross functional program or project manager in the biotech or pharmaceutical settings. 2. Outstanding interpersonal skills and be regarded as possessing strong leadership qualities while able to adapt style to situation. 3. MBA preferred, PMP a plus. 4. Excellent organizational and communication skills. 5. MS Project, Excel, Word, Visio 6. Ability to speak Mandarin not required but considered a plus __________________________________________________________ Director/ Associate Director; Quality Assurance - CA (Mandarin skills) Bachelor's degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 7 years experience in QA oversight of pharmaceutical development and manufacturing. Ability to fluently speak, read and write Mandarin. Small molecule experience. Desirable but not required: knowledge of cell culture and purification processing and associated batch record review of biologic manufacturing. Experience with API & chemical drug product manufacturing QA oversight of manufacturing of (CTM) and Commercial Products. Practical knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release. Working knowledge of US and EU cGMP regulations and guidelines. Experience in auditing suppliers and CMO’s. Strong planning and time management skills and ability to prioritize own work. Strong leadership and influencing skills a must. Knowledge of regulatory compliance of medical device manufacturing a plus. Some travel required. __________________________________________________________ Associate Director/Director; Clinical Quality Assurance - CA Must have a BS/BA or MS/MA degree in a related discipline. A minimum 7 years of related experience or MS/MA degree in related discipline and minimum five 5 years of related clinical QA experience. Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives. Excellent verbal and written communication skills, ability to work well in teams or independently and able to prioritize work. Manage multiple projects while maintaining quality and advocate for compliance. Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented. Experience working with clinical sites, developing SOPs in for quality assurance and compliance, all phases of clinical development and creating quality systems in a small company environment. Uses expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways. Ability to deal with ambiguity; creative and pragmatic approach to problem solving. __________________________________________________________ Associate Director/Sr Statistical Scientist, Biostatistics - CA

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•Ph.D. in Biostatistics or Statistics with 6 years of experience in biostatistics, with extensive experience within the pharmaceutical and/or biotechnology industries. •Possess a thorough understanding of the functioning of Biostatistics, Statistical Programming functional areas. •Thorough knowledge of statistical methodology, clinical experimental design and analysis for oncology therapeutic area especially in breast cancer. •Substantial knowledge of one or more clinical subject matter area. Requires proficiency in SAS and an understanding of clinical data processing. Knowledge of other statistical and computational software packages (Splus, EaST, nQuery) is required. •Knowledge of FDA and ICH regulations/requirements as they pertain to the analysis, presentation/reporting, and monitoring of data. •Effective interpersonal skills and strong written and oral communication skills. The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure. Strong motivation to succeed. •Knowledge of CDISC requirements for SDTM and ADaM. •Prior experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions will be preferable. __________________________________________________________ Specialist; Statistical Programmer - CA •Bachelors or Master’s degree; in Computer Science; Statistics; Mathematics; Life Sciences or other relevant scientific subject •Computer programming using SAS •Understanding of computer operating systems; word processors; document applications •Fundamentals of project planning and management •Drug development process Preferred: •12 years’ clinical research and development programming experience •Extensive hands-on experience in developing CDSIC standard specifications and datasets (SDTM; ADAM) •Experience in Oncology Trials •Experience in FDA/EMEA trial submissions •Drug Development (pre; early; late and/or observational) in related industries or academic research __________________________________________________________ Senior Biostatistician - CA •Ph.D. or M.S. in statistics, biostatistics, or related field with 4 (Ph.D.) – 6 (M.S.) years of experience as a project biostatistician in the biotech/pharmaceutical industry or medical research. In-depth knowledge of study designs and statistical analysis conventions in oncology areas a plus. •Experience with protocol development, clinical study reporting, ISS/ISE requirements, and regulatory submissions in paper and electronic format is essential. •Excellent verbal and written communication skills are required. •Comprehensive knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS, are a must. •Able to collaborate effectively with internal and external (e.g., CRO, corporate partners) study teams to meet project timelines. •Must be able to translate clinical study designs into statistical practice and educate study team members in the use of statistics. •Good interpersonal and project management skills are essential. __________________________________________________________

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Manager, Statistical Programming - CA BS Degree (MS preferred) in Computer Science, Biostatistics, Statistics, or a related quantitative discipline. Minimum of 10 years (12 years preferred) of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Additionally, the successful candidate must minimally possess abilities in the following: Knowledge of using SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Ability to clearly communicate processes and standards with management and team members. Constructing technical programming specifications. Working in a team environment. Leading projects and teams. Knowledge of CDISC SDTM and ADaM models and experiences in transforming raw data into those standards. Knowledge of: Relational Databases, Good Clinical Practices, Good Programming Practices, 21CFR Part 11 Standards, Integrated Summary Safety/Efficacy Analyses, NDA/ BLA submissions, Safety data and Coding Dictionaries (MedDRA and WHODD), Creating all documents necessary to support an electronic submission in the eCTD format. __________________________________________________________ Project Management, Early Development - CA •Bachelor's Degree or equivalent experience, preferably in a scientific discipline (Biology, Chemistry, etc.); advanced degree is a plus •A minimum of 5 years relevant pharmaceutical or biotechnology industry experience •A minimum of 3 years of demonstrated experience in project management / project coordination and collaborations is required •Demonstrated analytical and organizational skills (data basing, timelines, budgets) •Practical knowledge of small molecule drug discovery research, preclinical development, and CMC activities •Superior organizational skills and excellent communication skills •Proficiency in MS Office and prior exposure to timeline software tools (e.g. MS Project) is required •Flexibility and creativity to adapt to changes inherent within a research environment •Original thinker with good problem-solving skills •Must be a good team player and possess strong interpersonal and facilitation skills. The ability to interact effectively with resources at all levels within the organization is required __________________________________________________________ Director of GMP Quality - CA •Minimum 10 years of Quality Assurance experience in pharmaceutical industry. 5 years of which includes management experience •Extensive working knowledge of GMP regulations and experience with regulatory compliance inspections •Strong knowledge and experience with 21 CFR210, 21 CFR 211, ICH Q7 as well as international regulations •Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems •Ability to effectively lead teams and manage staff •Excellent interpersonal skills, including listening, writing, negotiation, facilitation, attention to detail •Must possess strong presentation skills to speak effectively before groups; ability to respond effectively •Must be willing to travel approximately 25%

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•Bachelor of Science degree in a related scientific discipline __________________________________________________________ Manager, Quality Assurance - CO or CA *Strong technical, analytical and writing skills to identify and solve problems and document them appropriately. *Ability to exercise independent judgment in making decisions to assure product quality. *Working knowledge of drug development process, FDA/EMA/ICH guidelines and GMPs, especially as applied to small molecule development, IV and oral dosage forms. *Working knowledge of validation as applied to pharmaceutical manufacturing, testing and equipment. *Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World. *Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding fast-paced environment. *Excellent oral and written communication skills for effectively interfacing with other departments within the company, suppliers, and other contractors. *Demonstrated audit conduct and management experience is desired. *Strong technical, analytical and writing skills to identify and solve problems and document them appropriately. *At least five years experience in a quality role within a pharmaceutical development setting required. *A degree in Pharmacy/Pharmaceutical Sciences, Chemistry, Analytical Chemistry or related scientific discipline is desirable. *Expertise in the areas of CMC, Quality and Regulatory. *This is an office based position with some travel. __________________________________________________________ Quality Assurance GCP Manager/Senior Manager - CA •BA/BS in Health Science or related field •At least 4-6 years Clinical QA experience, including internal/external GCP audits, is required •Demonstrate a thorough knowledge of GCP regulations and guidelines •Excellent written, oral and interpersonal skills __________________________________________________________ Sr Director of Business Development - S CA Minimum requirements: A strong work ethic and ability to lead multidisciplinary teams A combination of PhD (preferably in a biological discipline) and MBA is most desired At least 5 years experience in business development, financial modeling or quantitative marketing A track record demonstrating strong analytic skills in market assessment, valuation, IP analysis, and technical analysis Familiarity with use of business and financial databases; and analytic methods Strong communicative skills with ability to rapidly generate MS Excel and Powerpoint based presentations and to present them effectively to Sr. Management Ability to generate accurate and timely budgets Other desirable qualifications: Demonstrated strong personnel management skills Experience in diagnostics Knowledge of CPT and disease coding Familiarity with Laboratory, Marketing and Sales organizations Familiarity with Pharma organizations

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******************************************************* Apply on company website. To apply, please use this link: http://www.mybiotechcareer.com/JD/ClinicalResearch-Affairs-Job-Biotechnology-California-NorthRegion-12568 Clinical Laboratory Scientist Sterling Life Sciences - California- North Region (Greater Los Angeles Area) Job Description or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Perform screening or confirmation tests in accordance with laboratory standard procedures 2) Perform confirmation tests on positive samples 3) Calibrate laboratory equipment as required 4) Provide assistance, training, and support for unlicensed testing personnel and new employees 5) Calibrate gamma counter and gas chromatographs daily 6) Prepare reagents 7) Read chromatograms 8) Interpret and Report RIA results, 9) Troubleshoot problems, 10) Review problem specimen 11) Perform equipment maintenance TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description

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Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 10, 2012 Type: Full-time Experience: Mid-Senior level Functions: Project Management, Research, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12568 Job ID: 3541368 ********************************************* To apply, please use this link: http://www.mybiotechcareer.com/JD/ClinicalResearch-Affairs-Job-Biotechnology-California-NorthRegion-12242 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Clinical Operations Manager Sterling Life Sciences - California- North Region (San Francisco Bay Area) Job Description Partial Job Description 1) Develop the infrastructure for a clinical research and clinical operations unit, including aspects such as staffing, training, finance/budgets, drug development process and business development 2) Develop and implement sponsor or product-specific strategies for consumer products testing 3) Manage and provide feedback to study managers in writing protocols, study concept

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documents and operational feasibility of proposed studies 4) Provide direction to study coordinators regarding issues relating to study design, study endpoints/objectives, protocol writing, CRF and other study specific tools 5) Establish relationships with outside sites, vendors and ensure company is proficient in timeline management, budgets and quality assurance 6) Develop and maintain relationships with key opinion leaders and service providers in cosmetic, consumer products and dermatology TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 13, 2012 Type: Full-time Experience: Mid-Senior level Functions: Project Management, Research, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12242 Job ID: 3241194 ************************************************** To apply, please use this link:

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http://www.mybiotechcareer.com/JD/ClinicalResearch-Affairs-Job-Biotechnology-California-NorthRegion-12224 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Global Clinical Project Manager Sterling Life Sciences - California- North Region (San Francisco Bay Area) Job Description Partial Job Description 1) Manage multi-site international cosmetic, dermatology and consumer products clinical trials, including the safety and efficacy of products for a global pharmaceutical company 2) Develop, implement and monitor project plans to ensure projects meet all predetermined milestones, remain within contracted scope of work and within budget 3) Train and mentor an international team of study coordinators to ensure clinical study sites strictly adhere to specific protocols and that sites follow all SOPs and ICH GCP guidelines 4) Negotiate contracts and develop customer-oriented relationships with all sponsors and vendors and report the progress and issues to those parties throughout the course of the study 5) Monitor various clinical consumer products trials to ensure strict protocol adherence, patient compliance and adherence to GCP/SOPs 6) Write study protocols and CRFs and monitor their effectiveness in consumer product trials 7) Recruit and qualify study coordinators/ investigators/sites/subjects for consumer product studies TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm

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We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 13, 2012 Type: Full-time Experience: Mid-Senior level Functions: Project Management, Research, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12224 Job ID: 3241195 ******************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/ClinicalResearch-Affairs-Data-Statistics-Job-Biotechnology-California-SouthRegion-12433 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Project Manager - Data Management (Clinical) Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Work collaboratively with clients, Clinical Research and Executive Management to ensure that data collected during clinical trials are processed according to corporate standards, client requirements and contract specifications and that the data meets FDA guidelines for data integrity 2) Act as primary liaison between Data Management and the client, other departments (especially Clinical Research) and external vendors for all matters related to the conduct of the Data Management component of a protocol 3) Manage and coordinate all aspects of the Data Management of a protocol in accordance with the contract, client requirements and corporate standards 4) Oversee and coordinate the day-to-day activities of the Data Managers, Data Processors and Programmers assigned to the protocol

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5) Ensure that clinical data review policies, guidelines and procedures are followed during day-to-day processing of clinical data 6) Supervise the development and maintenance of protocol specific documentation as well as review and approve such documentation TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 13, 2012 Type: Full-time Experience: Mid-Senior level Functions: Engineering, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12433 Job ID: 3397719 ********************************************* Senior Project Design Engineer Sterling Life Sciences - California- South Region (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/Engineering-Job-Biotechnology-California-SouthRegion-

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17339 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Take responsibility for full life cycle design and development of class I medical devices which includes initiation, design, development, execution, and product maintenance 2) Design components or functional systems, and modify existing designs to develop or improve products and facilitate manufacturing operations. 3) Recommend alterations to development and design to improve quality of products and procedures 4) Determine budgets and timelines for assigned projects 5) Maintain design history file for assigned projects, adhering to company design control procedures 6) Initiate, complete and maintain change requests for assigned projects 7) Provide technical support to regulatory department 8) Support Marketing and Product Management with technical information to be used for training and marketing of assigned products 9) Support manufacturing vendors to provide processing improvements 10) Support surgeon and distributor customers by training and educating on technical aspects of assigned products as required 11) Determine necessity of testing and initiate testing of assigned products 12) Report progress and status of assigned projects on a timely basis to VP Engineering 13) Ensure CAD drafting and drawing maintenance 14) Research materials, new suppliers, components, parts and competitor products 15) Assist company personnel with engineering related issues wherever required TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson &

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Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 28, 2012 Type: Full-time Experience: Mid-Senior level Functions: Engineering, Science, Manufacturing Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 17339 Job ID: 3641548 ******************************************* Quality Engineer Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/Engineering-Job-Biotechnology-California-SouthRegion-17331 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Handle supplier quality - resolve issues, perform quality system and technical / process audits and corrective actions 2) Act as a chairperson for weekly MRB meeting

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3) Provide QA / QC support for production, purchasing, engineering and customer service departments 4) Train employees on FDA QSRs and ISO requirement 5) Maintain equipment for calibration and preventative maintenance program 6) Perform detailed and internal quality system audits 7) Host product safety inspections, including all required follow up TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 28, 2012 Type: Full-time Experience: Mid-Senior level Functions: Engineering, Quality Assurance, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 17331 Job ID: 3641545 ********************************************

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To apply, please use this link: http://www.mybiotechcareer.com/JD/ClinicalResearch-Affairs-Manufacturing-Engineering-Job-Biotechnology-California-12399 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text)

Vice President of Operations

Sterling Life Sciences - California (Greater Los Angeles Area)

Job Description

Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Responsible for management of all site operations including development and manufacturing operations along with QA, QC, regulatory support operations and logistics. 2) Strategic planning, preparation and implementation of annual budgets, cost control, helping to ensure full compliance with GMP requirements and maintaining quality, service and on-time delivery. 3) Lead and manage the development and manufacturing operations to ensure efficient production of products consistently meeting quality, quantity and time-line objectives. 4) Ensure the company maintains qualified well-trained staff, leading technology and GMP compliant facilities to maintain its leadership position in process development and cost-effective manufacturing of products. 5) Leadership role in strategic planning and investments. 6) Interact closely with Global Sales & Marketing to ensure efficiency, flexibility and market responsiveness. 7) Promote a smooth and efficient cooperation between Development and Production to ensure simple and cost effective start-up of production of new products. 8) Oversee an integrated quality program to ensure continuous product and process improvement. 9) Encourage communication and efficient cooperation across departments and other company sites. 10) Oversee logistics for project planning, cost control and supply of materials for production. 11) Oversee Quality Control and Quality Assurance to ensure timely GMP-compliant quality

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control of raw materials and finished API products, and full GMP compliance for all products manufactured on site. 12) Oversee maintenance of buildings and equipment. 13) Ensure efficient development of human resources through continuous performance review and establishment of objectives for all personnel. 14) Preparation and realization of site expansion and other investment projects. 15) Actively implement policies and procedures established by the company. 16) Reporting of site performance metrics. 17) Ensure compliance with health, safety and environment legislation. TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility

Company Description

Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at:

http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm

We respect your privacy. Your resume will *never* be shared without your permission.

Please add our CEO on LinkedIn - your invitation will be accepted: [email protected]

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Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials.

Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume.

Additional Information Posted: August 10, 2012 Type: Full-time Experience: Executive Functions: Manufacturing, Management Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12399 Job ID: 3541387 ********************************************* Apply on company website. More info at http://www.linkedin.com/company/4430/careers?trk=jobtocomp Director, Business Development (Drug Discovery Services)-HOME-BASED PPD - US-California-San Francisco (San Francisco Bay Area) Job Description The Director, Business Development will support BioDuro, A PPD Company, a drug discovery services company focused on integrated drug discovery programs. The Director, Business Development will secure and retain business for PPD through professional, consultative, proactive sales activities directed at decision makers and decision influencers at existing and new medical communication sponsors. Oversee the sales activities (including, but not limited to cold calling, proposal writing, contract negotiation, sales presentations, support of client relations) and position PPD as a primary or preferred provider for all professional drug discovery services to be outsourced. **POSITION TO BE HOME-OFFICE BASED ON THE WESTCOAST--BAY AREA PREFERRED, BUT OPEN TO SAN DIEGO OR OTHER WESTCOAST LOCATIONS** Qualification Education and Experience:

Bachelors degree in science or business (Master's/PhD considered a plus) 5+ years sales experience in biotech/pharmaceutical/CRO (discovery sciences required) Or equivalent combination of education, training and experience that provides the

knowledge, skills and abilities to perform the job Knowledge, Skills and Abilities:

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Computer skills to handle sales automation, word processing, spreadsheets, power point and email

Excellent oral and written communication skills Ability to manage people and tasks Problem solving Sales skills Contract negotiation skills

PPD is an Equal Opportunity Employer Company Description PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 45 countries and more than 11,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com. Additional Information Posted: August 29, 2012 Type: Full-time Experience: Not Applicable Functions: Sales, Business Development Industries: Biotechnology, Pharmaceuticals, Research Employer Job ID: 106628 Job ID: 3649511 ******************************************************* Cheryl Grimes, Medical Device Practice Leader [email protected] MRIGlobalMedDevice.com D: 443 921 9021 I'm working on 2 positions - a R&D Program/Project Manager (would also consider Staff Manager) and R&D Engineer with a well established, long standing medical device co. You can contact me directly @ [email protected]. . Mid-sized publicly traded co in Florida - excellent standard benefits; Tuition reimbursement; $ for $ 401K match up to 7%; Employee stock purchase plan . Lot of energy and dynamics - nice size that offers oppty to have influence on direction of product lines - oppty to leave a silo organization . Employee centric-team-oriented environment; synergistic with good cross-functional team collaboration . Strong culture of Continuous Improvement . Nice area to live; warm weather year round for all year activities; water access; great park system; great for outdoor lovers . Nice blend of Cultural Arts and metropolitan environment while not being in a mega-city . Centrally located in area with many community choices for living; Counties with very good school systems and many new programs that offer collegiate-like experiences . Perhaps an opportunity to get back to your roots . High impact and visibility position - growth and advancement opportunities - positions are expansion positions Background profile for R&D Engineer:

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. BS Engineering

. 3+ years of medical device product design/development exp - at least 2 years of ortho or spine implant . 3D solid modeling-hands-on design exp . GD&T; elements of design; testing for DHF . Exposure to all stages of full product development cycle, cradle to grave . Plus is project management experience Background profile for Program/Project Manager or Staff Manager: . Bachelor's Degree - Technical Degree (BSEE preferred) . Hands-on engineering exp (working mgr position) as outlined in R&D Engineer role above but with 7-8+ years of exp (ortho or spine implant) . Must have extensive project mgt-cradle to grave - stage/phase gate exp to include PM tools (MS Project or similar) I hope to talk to you further, Cheryl Cheryl Grimes Medical Device Practice Leader About me: I am an executive recruiter with MRIGlobalMedDevice, specializing in the medical device industry where our team has focused for over 12 years. We are deeply committed and connected to the medical device/biotech space and have a successful track record and reputation with assisting medical device/biotech professionals with their careers. *************************************************** https://jnjc.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=57359 Product Director- US Marketing-0371120302 We are actively recruiting for a Product Director to join the Marketing team at Codman in San Jose, CA. We are looking for a seasoned marketing professional with strong Global upstream and/or US downstream experience. Based on your background, I wanted to see if you or anyone you know may be interested. Details of this position can be found in the link below. Thanks for taking a look. Description Codman Neurovascular, is recruiting for a Product Director, US Marketing, located in San Jose, California. Codman Neurovascular is a business unit within Codman & Shurtleff, Inc., a global neuroscience device company with a long history of innovation. Codman Neurovascular focuses on advancing minimally invasive stroke prevention and management, including the treatment of hemorrhagic and ischemic stroke, brain aneurysms and vascular malformations. Headquartered in San Jose, CA, Codman Neurovascular employs approximately 770 people worldwide, and markets one of the most comprehensive lines of neurovascular devices, including diagnostic and interventional access catheters, micro coils, endovascular stents and liquid embolics. As part of DePuy and the Johnson & Johnson Family of Companies, we are in a unique position to bring forward therapies that enhance existing treatments and help transform neurological care, to make a real difference in the lives of patients. We continue to expand our range of treatment solutions, and in 2010, the acquisition of Micrus Endovascular further strengthened our neurovascular product offerings. The Product Director will be responsible for the marketing management of Codman Neurovascular products in the US. Primary role is to provide decisive leadership in all areas of the marketing mix related to branding, market segmentation, product positioning, channel

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strategies, pricing and competitive dynamics. Will develop business plans through marketing strategies, goals, and tactics. Will work closely with field sales organization and customers, NPD and Regulatory to effectively navigate the internal environment and achieve results. Identify product life cycle needs and launch new products and indications. Responsible for maximizing physician acceptance, market penetration, and often the profitability of a particular major product or brand, or small group of related products or product lines. Coordinates the work of specialists (in-house and external) in such activities as product and other promotions, sales training, and often costing and pricing. Develops and executes comprehensive brand strategy and marketing plans(s). Forecasts customer demand and participates in review of sales and demand forecasts for assigned product line or across product lines. Provides leadership, support and expertise to the sales organization and distribution channels for the product line. Qualifications A minimum of a Bachelors Degree is required. An MBA is preferred. A minimum of 5 years of marketing or marketing related experience (such as sales, business development, franchise development) is required. Interventional medical device marketing experience is preferred and neurovascular experience is a plus. Demonstrated experience in marketplace assessment, product positioning, and brand marketing is required. Product launch experience is required. Strong analytical, written and oral communication, and presentation skills are required. Experience with collaboration, influencing without authority and working across cross-functional teams is required. This position requires approximately 30% travel domestically, including weekends. This position requires working in an Interventional Suite setting. This position is located in San Jose, CA. BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. Primary Location North America-United States-California-San Jose Organization Codman & Shurtleff Inc (6087) **************************************************** Interested candidates may contact me directly at [email protected] bionexsolutions.com bionexsolutions.com Applications Scientist/Engineer (SF Bay Area) BioNix Solutions is an emerging life science instrumentation company focused on the unmet needs of customers in the lab automation and liquid handling markets. We're seeking an Applications Scientist/Engineeer who'll be the liaison between our customers, sales, and engineering. This individual will listen to our customers' needs, help solve their technical issues, optimize our products to meet their specifications, and understand industry trends that impact future gnerations of BioNex Products. Candidates must have demonstrated expertise with the following: - Testing liquid handling instrument performance (precision and accuracy) - Conducting technical presentations at professional conferences and with customers - Performing product tersting and demonstrations - Mapping customer needs to product applications - Analyzing and interpreting data Position requires a BS/MS in related life science (biochemistry, bioengineering, molecular

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biology, etc. with demonstrated related industry experience. Up to 35% travel is required. Relocation assistance is not available. ******************************************************* Apply on company website Regional Education Manager Siemens Healthcare - San Francisco or Los Angeles (San Francisco Bay Area) Job Description Plan and manage the Siemens Education Services business within a region. Own the relationship between Education Services and internal/external customers within the region. Establish and implement the Clinical Education business plan for designated region by understanding regional market demands, trends, major accounts, target accounts, competitive landscape and customer/business requirements, resulting in growing Education Services revenue, profits, customer satisfaction and Net Promoter Score. This position will help to reduce geographic coverage to support improved customer intimacy and realize 60% customer face time. This position will improve the manager / employee relationship and help to effectively manage escalations in the field. They will support a more collaborative customer sales and service support model. Desired Skills & Experience 5-8 years of management experience or an equivalent combination of education and experience is required. Additionally, knowledge of imaging equipment and P&L is also required. The ideal candidate should be able to demonstrate an understanding and application of management approaches for work direction, motivation, performance management and disciplinary action. Must have strong communication skills and the ability to work with all levels of management. This position can reside in or around San Francisco or in or around Los Angeles Company Description Siemens Healthcare, a sector of Siemens AG, is a leading healthcare solutions provider worldwide. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services. The portfolio of innovative products and professional services ranges from clinical and administrative IT solutions, diagnostic imaging systems, laboratory diagnostics, and hearing instruments. Additional Information Posted: August 21, 2012 Type: Full-time Experience: Mid-Senior level Functions: Management Industries: Medical Devices Employer Job ID: 115393 Job ID: 3602968 **************************************************** Apply on company website Research Leader Roche - Pleasanton, US-CA (San Francisco Bay Area) Job Description

Broad understanding of the organization’s vision, knows what it means for the area(s), team, and aligns goals to the vision. Responsible for short to mid-term (0-10 years) focus on business. Involved in establishing and implementing operating policies and procedures

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that effect own area(s). Develops product concepts and specifications, and translates into focused scientific activities. Plans and designs advance independent or multi-disciplinary research/development experiments driven by strategic business needs. Manages projects and team, providing scientific/technical direction to staff. Prepares timelines and assessments of project progress and critical factors, and establishes priorities. Assumes responsibility for timely completion of projects, and resolves technical issues. Ensures activities meet performance/quality expectations and are consistent with project critical path. Ensures technical activities under delegated supervision are conducted within of internal and external guidelines and regulations. Interacts with other departments to further project goals. Recommends new approaches, expansion or curtailment of project technical activities based on experimental results or new scientific information. Adjusts direction of research activities accordingly as scientific findings warrant. Communicates progress of efforts to Director and other departments to assure awareness of current status of projects.

Provides top line review of experimental results, and secondary review of experimental data. Prepares comprehensive written and verbal project status reports, and written manuscripts for publication in some cases. Presents findings or comprehensive project status reviews at internal & external meetings. Applies advanced technical writing skills to produce reports and documents.

Manages projects and assigned staff, provides scientific/technical direction, and designates accountability for product research and development activities. Gives people assignments and training to develop their abilities.

Responsible for the transfer of product technology and documentation from Research to Development and/or to Manufacturing. Provides information and assistance to other departments to support product scale-up, manufacture, launch and sales.

Influences senior management decisions that have an impact on business direction of the area

Makes decisions under consultative direction that impact broad company objectives.

Desired Skills & Experience Education:

Master's degree in Biological/Life Sciences, Chemistry, Biochemistry or related field and typically 8+ years relevant experience, or equivalent combination of education and work experience, requried.

Ph.D. and 0 to 3 years combined relevant post-doctoral and industry experience; or Master's degree in Biological/Life Sciences, Chemistry, Biochemistry or related field

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and typically 10 to 12 years relevant experience, or equivalent combination of education and work experience, preferred.

Experience: Typically 8+ years of relevant industry

experience. Progressive supervisory/management experience, required.

Other Qualifications: Displays solid leadership skills. Project

management experience. Knowledge and experience in experimental design, data analysis, and data and concept presentation. FDA product regulatory experience highly desired. Knowledge of quality systems regulations. Negotiation skills.

Company Description Roche Molecular Systems Inc. Additional Information Posted: August 27, 2012 Type: Full-time Experience: Mid-Senior level Functions: Research, Science Industries: Biotechnology, Pharmaceuticals Compensation: 0 Employer Job ID: 00398189 Job ID: 3640159 ***************************************************** Contact Jon Guidi http://bull.hn/l/O789/5 If interested in following job, write I'm interested in your "Job #406971: Area Vice President, Home Health" job in Sacramento, CA. Please contact me about the position.

Location Sacramento, CA Salary/Pay Rate 150k+

Employment Type Full Time Job Description

Title: Area VP of Operations

Salary: 135-170K + bonus + benefits

A leading player in the Home Care industry seeks an Area Vice President to manage the Operations of their 7 Branches in Northern CA. This organization has a great reputation of providing high quality patient care. Must reside in Northern CA - 7 Branches are all located fairly close together so travel is minimal.

Requirements: - Healthcare management/operations professional with 8+ years experience

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- Must have CURRENT OR VERY RECENT Home Healthcare experience - managing multi-site (preferably 3+) locations

- Prefer RN by background; may consider other clinical or even non-clinical candidates if really strong in operations for multi-site locations.

________________________________________________

Jon Guidi http://bull.hn/l/O789/5 I'm interested in your "Job #290220: Client Manager ( Home Care)" job in San Francisco, CA. Please contact me about the position.

Location San Francisco, CA

Salary/Pay Rate 90k+ excellent benefits

Employment Type Full Time Job Description

Work as a Client Manager for a well established and growing Home Care services company who is fully committed to excellence. By utilizing incoming referrals and generating your own referrals from outside sources, you will establish and maintain long lasting relationships with families/individuals who are in need of Home Care services. You will be fully trained on how to conduct in home assessments. Once these assessments are made you will match the correct caregivers with your clients in need. This individual will need some sales aptitude for contract sale purposes, but will be more care focused and client focused. You will act as the face of the business and carry out marketing responsibilities and community outreach activities.

*Prefer candidate to live on the Peninsula - Redwood City, San Carlos, Belmont, San Mateo, Burlingame, Millbrae, San Bruno, Pacifica, South City, etc Will consider SF based residents

This is an opportunity for a very passionate, personable, entrepreneurial spirit who has a passion for the Geriatric population. Business minded. If this description fits you...please apply with me today!

******************************************************* Amanda McDermott URGENTLY seeking a Sr / Pr Computational Biologist for a Global Biopharmaceutical Company in San Francisco. Main Criteria - RNA-seq, NGS, R - Leadership responsibilities - contact me 415-796-8050 ******************************************************

Jobs That Crossed My Desk Through August 26, 2012 ************************************************************* For immediate consideration, send your resume to our recruiter: [email protected] Senior Operations Director

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Prestigious institution is searching for a Senior Operations Director. Under the general direction of the Administrator, and technical direction of the Medical Director, the Sr. Operations Director is responsible for the administrative and technical management of operational departments, including but not limited to:

Donor Services Technical Services Information Systems Marketing/Communications Projects and Scheduling.

The Sr. Operations Director supervises daily operations of the department; coordinates necessary administrative and supervisory staff to provide necessary services and ensure adequate blood supply is available to customers. Manages department heads and supervisors to develop, evaluate and adjust organizational structures and systems to assure accomplishment of Center mission(s) in the most effective and economical manner. Participates in facilities planning; provides effective space management; plans and initiates changes to existing facilities and capital equipment; performs long range policy, personnel and fiscal planning. The Sr. Operations Director assumes overall Center administrative responsibilities in the absence of the Administrator. Develops and approves operational policy and oversees implementation of policies, interprets and applies Hospital and/or University policies and procedures, assures that the department complies with governmental regulations and those of other inspecting agencies. Participates in, and analyzes, budget preparation for the Center, authorizes expenditures of approved funds, and recommends reallocation of funds based on spending trends and projections and program requirements. Serves as department representative in meetings on matter of Center concern; in the absence of the Administrator, represents the Center at local, state and national meetings. Interviews, hires and evaluates operational supervisory staff. Oversees timely collection of statistical data for Center, and incorporates data patterns into operational decision-making. Serves as key member of the Center Administrator’s Executive Management team. Requirements: Bachelor's Degree in Business Administration, public health or related field required. Minimum of five years blood bank or health care experience required. Applicant must have history of progressively responsible management experience and demonstrated managerial ability. Must be able to communicate effectively with all levels of hospital personnel, physicians and the general public and be able to exercise sound independent judgment. Proficiency with personal computer, including word processing, spreadsheets and databases, required. Will be required to comply with governmental regulations and University and Center policy and strictly observe privacy and security related policies, procedures and practices to preserve the integrity and confidentiality of medical and other sensitive information pertaining to donors, patients, research subjects, and staff. Will be required to enter areas where other

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individuals work with human blood; potential may exist for unanticipated exposure to bloodborne pathogens by splash or spill.

******************************************************* Invite to connect and send resume to [email protected] Jake Mosberg Search Consultant Global Recruiters of Wilmington (302) 455-9500 x107 [email protected] Site Director – Pharmaceuticals – Long Beach, CA We are working with a producer of API’s to find a Site Director of Engineering at their flagship site to lead manufacturing operations, as well as all of the business and support functions at the site. This is a key leadership position reporting directly to the CEO. Requires a BS in a related Engineering or technical field and 10+ years operations experience in Pharmaceuticals, Biotechnology or fine chemicals. Management skills across multiple departments and experience driving positive change are key factors in the selection process. Excellent growth opportunity with stable company. Relocation available only within the U.S.; No International candidates. ****************************************************** Apply at company website at http://www.linkedin.com/company/24162?trk=jobtocomp Manager/Sr. Manager Quality Assurance CMC Biologics A/S - San Francisco Bay Area Job Description Job Title: Manager/Sr. Manager, QA Location: Berkeley, CA Department: Quality Assurance Requisition #: 2000 Responsibilities: The Manager of the Quality Unit is responsible for coordinating and managing the day to day activities of the Quality Unit operations group including some basic Quality Control functions. This includes management and oversight of programs and staff to support:

Facility monitoring (environmental and utilities) Sampling and labeling of incoming materials Lot review of all clinically manufactured products Review and approval of compliance documentation for utilities, facilities and equipment

necessary for production and testing of clinical products. Act as Quality representative on facility start up activities Transfer and maintain CMC Biologics existing quality systems at the Berkeley, CA site.

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Desired Skills & Experience BS or MS in life sciences. 10+ years in QA within a cGMP environment. 5+ years

supervising staff. Hands on experience in quality operations (i.e. plant operations, alert/action systems,

facility equipment change over, line clearance, etc.) and quality systems (i.e. change management, deviation system, CAPA, auditing, etc.) related to biopharmaceutical manufacturing, including interactions with Health agencies (i.e. FDA or EMA) is required.

Knowledge of environmental monitoring techniques and industry best practices. Knowledge of raw material testing and sampling procedures. Knowledge of US and EU cGMP and regulatory guidelines is required. In depth knowledge of quality systems and how quality systems are designed and

operated to satisfy US and EU regulatory requirements. Experience in writing, reviewing and approving SOPs, master batch records, deviations,

CAPAs and change control records is required. Experience with microbial and cell based production and purification technologies is

preferred. Experience with equipment qualification and process validation is preferred. Direct participation in a FDA inspection or other regulatory inspections/audits is

preferred. California FDB pharmacy exemptee license preferred.

CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE Company Description CMC Biologics A/S is a contract manufacturing organization, with manufacturing facilities in Europe and the USA. The company offers a wide range of integrated cGMP manufacturing services using microbial fermentation and mammalian cell culture processes. CMC’s Copenhagen Manufacturing Facility is the first CMO in Europe who has a 2000 Liter Single-use Bioreactor . CMC's headquarters are located in Copenhagen, Denmark, part of Medicon Valley region. Its US facilities, are located in Seattle, WA and Berkeley, CA. Our Mission is to realize the potential of our customers’ biopharmaceuticals by contract process development and manufacture. Our Vision is to be a world market leader in biopharmaceutical contract services in term of quality, know-how and timeliness. Additional Information Posted: August 24, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Biotechnology Job ID: 3629105 *********************************************************

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Shelly G., Technical Recruiter at ProPharma Group

Cleaning Validation Gap Assessment Consultant - Southern, CA

Now hiring: Cleaning Validation Gap Assessment Consultant - Southern, CA. For immediate consideration, please apply directly at http://propharmagroup.com/Careers.aspx. http://www.ziprecruiter.com/job/Cleaning-Validation-Gap-Assessment-Consultant-Southern-CA/2e16279e/?source=social-linkedin-group-jobs

***************************************************** Amanda Rosales, Recruiter at SMR Group Ltd Email resume to [email protected]

Looking for specialty pharma reps w/ demonstrable over quota sales success in Houston North, TX, San Francisco, CA, Kansas City East, MO, San Diego, CA, Rome/Dalton, GA, Milwaukee South, WI ****************************************************** ******************************************************

Innovation & Discovery in Biopharmaceuticals…SENIOR CLINICAL SCIENTISTS, CLINICAL TRIALS & CRA positions at Celgene http://www.beaker.com/Celgene_Clinical

…CELGENE is a global biopharmaceutical leader committed to improving patient lives and named #12 on Forbes Top 100 Most Innovative Companies. Ready to join the team and contribute to Celgene’s scientific and commercial achievements? http://bit.ly/celgeneclinical

Celgene - Clinical Opportunities beaker.com

Beaker is an online community for life sciences professionals managing a career within the pharmaceutical, medical device, biotechnology, medical equipment, diagnostic, medical product and animal health sector.

************************************************ Apply on company website Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Senior Director of Global Regulatory Affairs Sterling Life Sciences - California (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/RegulatoryAffairs-Job-Biotechnology-California-12500 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter.

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Partial Job Description 1) Serve as a leadership team member for companys surgical regulatory affairs function 2) Oversee the development of global product regulatory strategies for all company surgical products 3) Oversee the regulatory functions in relation to device design and development as well as product approvals, consistent with company agreed upon timelines 4) Manage interactions with regulatory authorities for surgical products 5) Build relationships with regional and global company regulatory affairs teams 6) Provide regulatory support to other company functions (e.g. Quality, Compliance) during regulatory authority inspections 7) Provide regulatory guidance/input to internal product review boards 8) Select, develop and motivate a regulatory team that supports personal growth and a culture of compliance 9) Play a significant role in the performance management process and career development programs for supervised regulatory personnel TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: July 31, 2012

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Type: Full-time Experience: Director Functions: Science, Project Management, Quality Assurance Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 153 Job ID: 3477685 __________________________________________ Manufacturing Supervisor - Medical Device Sterling Life Sciences - California- South Region (Greater Los Angeles Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/Manufacturing-Job-Biotechnology-California-SouthRegion-12496 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Supervise controls and run production line with lead operators support 2) Lead initiatives to maintain a continuous improvement environment around the manufacturing operation that will reduce waste and increase productivity, quality and safety 3) Monitor production and adjust work assignments, supply of material and machine operation 4) Coordinate with different support areas of the organization (Supply Chain, Quality and Maintenance 5) Define, evaluate and change procedures for manufacturing processes according to regulations, internal and corporate procedures, and company specifications and policies 6) Maintain an appropriate labor-management relationship with subordinates 7) Show respect and sensitivity for cultural differences 8) Promote a harassment-free environment 9) Conduct root cause analysis and investigations to address quality or productivity issues 10) Coach manufacturing personnel to create a continuous improvement departmental culture 11) Align with general plant strategies by establishing supporting processes 12) Lead or support projects and validations 13) Control department expense budget within planned levels

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14) Interact with all levels of personnel to analyze and solve problems related to manufacturing, quality, documentation and personnel issues 15) Respond to detailed inquiries and present information to groups and senior management TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: July 31, 2012 Type: Full-time Experience: Mid-Senior level Functions: Management, Science Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12496 Job ID: 3477675 ************************************************ Please contact Nancy Symonds, President, NJS Recruiting Services, [email protected].

SR. DIRECTOR, GLOBAL QUALITY - VACCINES (SF BAY AREA)

NJS Recruiting Services has been retained by a vaccine company in the San Francisco Bay Area to conduct a nationwide search for a Sr. Director, Global Quality to join their team. Our client is a clinical-stage biopharmaceutical company that discovers and develops novel products to prevent and treat infectious and inflammatory diseases currently working in the areas of Hepatitis B, Flu and Lupus. Recently they filed their first BLA and MAA for their

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Hepatitis B Vaccine and anticipate approval next year. Our client seeks a QA professional with broad GXP expertise (GMP, GCP, GLP) to manage a staff of 6 and work closely and collaboratively with the staff of their German manufacturing subsidiary as well as the senior management team at headquarters. This position will have global oversight and leadership of quality systems and programs to meet compliance, validation, quality assurance requirements, which include Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP). Requirements include 20+ years industry experience with expertise in vaccines or biologics products and a track record of successfully building credibility for the QA function . A Competitive compensation package including relocation will be provided. A job description and additional information is available to interested candidates.

***************************************************

Apply at Real Staffing Group

Senior Equipment Engineer - $40/h - Peninsula

Real Staffing Group - San Francisco Bay Area

Job Description

I currently have two different medical device clients with sites in Redwood City, San Jose and Fremont both looking for Sr. Equipment Engineers to develop and design fixture and tooling solutions.

There are 4 open positions, all contracts spanning 6 - 12 months and paying $40/hour on a w2.

Qualified candidates will have strong design experience using Solidworks and be comfortable working in a manufacturing environment and integrating electronic subsystems into fixtures.

Please submit your resume for immediate consideration and I will contact you shortly.

Company Description

Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry

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hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results.

Additional Information Posted: August 22, 2012 Type: Contract Experience: Mid-Senior level Functions: Engineering Industries: Medical Devices Job ID: 3612591 ********************************************* To apply, please use this link: http://www.mybiotechcareer.com/JD/ClinicalResearch-Affairs-Manufacturing-Engineering-Job-Biotechnology-California-12399 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Vice President of Operations Sterling Life Sciences - California (Greater Los Angeles Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. Partial Job Description 1) Responsible for management of all site operations including development and manufacturing operations along with QA, QC, regulatory support operations and logistics. 2) Strategic planning, preparation and implementation of annual budgets, cost control, helping to ensure full compliance with GMP requirements and maintaining quality, service and on-time delivery. 3) Lead and manage the development and manufacturing operations to ensure efficient production of products consistently meeting quality, quantity and time-line objectives. 4) Ensure the company maintains qualified well-trained staff, leading technology and GMP compliant facilities to maintain its leadership position in process development and cost-effective manufacturing of products. 5) Leadership role in strategic planning and investments. 6) Interact closely with Global Sales & Marketing to ensure efficiency, flexibility and market responsiveness. 7) Promote a smooth and efficient cooperation between Development and Production to ensure simple and cost effective start-up of production of new products. 8) Oversee an integrated quality program to ensure continuous product and process improvement. 9) Encourage communication and efficient cooperation across departments and other company sites.

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10) Oversee logistics for project planning, cost control and supply of materials for production. 11) Oversee Quality Control and Quality Assurance to ensure timely GMP-compliant quality control of raw materials and finished API products, and full GMP compliance for all products manufactured on site. 12) Oversee maintenance of buildings and equipment. 13) Ensure efficient development of human resources through continuous performance review and establishment of objectives for all personnel. 14) Preparation and realization of site expansion and other investment projects. 15) Actively implement policies and procedures established by the company. 16) Reporting of site performance metrics. 17) Ensure compliance with health, safety and environment legislation. TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR,Pfizer,Merck,Amgen,Genentech,Healthcare,Life Sciences,Scientist,R&D,Ferring,Stryker,Boston Scientific,Medtronic,Abraxis,Gilead,Glaxosmithkline,Clinical Research,Clinical Trial,Regulatory Affairs,FDA,Johnson & Johnson,Schering,Nutreaceutical,Surgeon,MD,Hospital,Immunology,Medimmune,Abbott,Roche,Therapeutic,Hospira,Covidien,Quintiles,PPD,Parexel,Quality,QC,Validation,Engineer,QA,Manufacturing,Engineering,Aseptic,Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm We respect your privacy. Your resume will *never* be shared without your permission. Please add our CEO on LinkedIn - your invitation will be accepted: [email protected] Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn andfollow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted: August 10, 2012 Type: Full-time

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Experience: Executive Functions: Manufacturing, Management Industries: Biotechnology, Pharmaceuticals, Medical Devices Compensation: Superb. Commensurate w/experience. Employer Job ID: 12399 Job ID: 3541387 ******************************************** Emeryville Biostatistician I - CA, 94608 jobs.yoh.com Check out Emeryville Biostatistician I Job - CA, 94608 at http://jobs.yoh.com/job/Saint-Louis-Regional-CRA-Job-MO-63101/1005976/ ******************************************************** Apply Real Staffing System, San Francisco Bay Area office Manager, Quality Systems Real Staffing Group - SF Bay Area (San Francisco Bay Area) Job Description Global biotech and medical device supplier is urgently seeking a full-time Quality Manager to join their team. Please submit your CV if you meet the below requirements: *7+ years progressive Quality experience *Experience developing, implementing maintaining and auditing Quality Systems *Lead auditing experience of internal and external (supplier and customer) audits - any certifications are a plus *Strong knowledge of Quality Systems: ISO13485 and ISO9001 - any certifications are a plus *cGMP background *Relevant medical device, biotech or pharmaceutical experience *Experience leading and managing others *Familiarity with regulated environments *BA/BS in science related field

Company Description

Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results.

Additional Information Posted: August 21, 2012 Type: Full-time

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Experience: Mid-Senior level Functions: Quality Assurance Industries: Biotechnology Compensation: $110k - $125k Job ID: 3606644 ************************************************************ Apply on company website at http://www.ziprecruiter.com/jobs/Veracyte/bfe5e543 Lab Assistant - Temporary Assignment

Company: Veracyte Location: South San Francisco, CA Category: Biotech/Pharmaceutical

Job Description: The LA will assist clinical lab scientists with routine specimen processing in accordance with established protocols. Process specimens upon receipt in the lab, perform some specimen preparation, specimen verification and tracking, all related clerical functions (including data entry) and general lab maintenance tasks. Position requires a two year degree in the life sciences or a biotechnology certificate. Previous experience working in a laboratory environment required. High attention to detail and ability to problem solve is necessary. This is a temporary, full time six month assignment. Work schedule is Tuesday through Saturday. About the Company: Veracyte, Inc. is a commercial-stage diagnostic company pioneering the emerging field of molecular cytology. We have achieved significant success since the founding of the company four short years ago. We launched our first product, the AfirmaÂ® Thyroid FNA Analysis in the unprecedented time frame of two and a half years. This accomplishment resulted in The Wall Street Journal selecting us as one of the top 50 venture-backed companies out of over 5,000 companies considered in 2011. In January of this year, Medicare announced their coverage decision for the centerpiece of our thyroid solution, the Afirma Gene Expression Classifier, an innovative proprietary genomic test designed to classify inconclusive thyroid nodules obtained through fine needle aspiration in the doctor office as benign or suspicious for malignancy. Studies have shown the Gene Expression Classifier has the potential to help tens of thousands of patients each year avoid surgery while reducing cost to the healthcare system. Veracyte commenced a global co-promotional partnership with Genzyme, a subsidiary of Sanofi, a world leading biotechnology company, to make the Afirma solution available to patients and physicians across the US and all over the world. Veracyte has an exciting pipeline of products aimed at addressing other significant unmet needs including our lung program addressing difficult to diagnose lung diseases and cancer. ***************************************************** Cheryl Ward, CIR, Executive Recruiter at SciStaff Services, LLC Apply at http://www.postjobfree.com/apply-for-job/membd5/statistician-immunology-oncology-redwood-city-ca

State: California City: Redwood

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City ZIP: 94063

Job type: Full-time

Company Name: SciStaff Services

Posted date: 8/20/2012

Joined: 3/8/2011 all jobs all comments

Job Description: My client is seeking a Statistician to work with them in Redwood City, CA for approximately 6 months. Qualified candidates will have an advanced degree and pharmaceutical industry experience focusing on clinical trials in oncology or immunology. US based candidates ONLY, please - NO sponsorship, NO relocation If you meet the above requirements, please forward a copy of your resume (word format) to [email protected] for confidential review.

****************************************************************** Protein Purification Scientist Real Staffing Group - San Francisco Bay Area Job Description Protein Purification Scientist A biotech company in the South San Francisco area is looking for a Protein Purification Scientist to join their team. This is an urgent contract position and we are looking to identify someone immediately. The Protein Purification Scientist will work in the Purification Development department. Your responsibilities will encompass all the activities involved in carrying out chromatography experiments with CHO culture processes. The successful candidate will support the development and implementation of recombinant protein purification processes at laboratory scale. Activities will include the operation of chromatography operations, and analytical methods such as HPLC and electrophoresis. Desired Skills & Experience Protein Purification Scientist Requirements: The ideal candidate will display a strong focus on safety, quality, detail and results. Must be organized and capable of multitasking, have effective problem solving abilities, and demonstrated mechanical aptitude. Experience using the AKTA systems and Unicorn software is required. Communicates clearly, concisely and professionally in both verbal and written manners. This position requires the ability to effectively work in a team environment with diverse skills and objectives. Successful candidates must have a high level of demonstrated initiative, be self directed, exhibit flexibility in work approach, demonstrate strong follow through and accountability, and embrace positive change. A BS or MS in Biochemistry, Chemistry, Chemical Engineering or a related field is desired. An understanding of separation techniques in relation to protein purification, specifically using Unicorn software on the AKTA systems is required. Knowledge of analytical techniques applicable to protein purification is preferred. Experience with the design, execution and

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analysis of chromatography experiments is also desirable. The successful candidate should possess good problem solving, organizational, and documentation skills. The successful candidate should be self-motivated and able to work independently as well as in a team environment. Strong interpersonal, collaborative and communication skills are required. If you are interested in applying to this position, please reply to this job positing ASAP to be considered. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted: August 20, 2012 Type: Contract Experience: Mid-Senior level Functions: Science, Research, Quality Assurance Industries:

Biotechnology, Pharmaceuticals, Medical Devices Job ID: 3598839 ******************************************************************* Contact Please email Lindsey Summers at lsummers(at)pharmascent.com, or call at 303-694-5482. Medical Writer (Regulatory) – San Francisco Bay Area San Francisco Bay Area Contract position; client only allows W-2 work, and must be on site. Responsibilities

Prepares technical documents to support domestic and international regulatory submissions

Incorporates text, graphs, charts, tables and statistical analysis Proofreads, circulates, edits, assembles, inspects and duplicates product submissions

Qualifications Bachelor degree REQUIRED, advanced degree preferred 5+ years experience with Clinical Regulatory Writing

_______________________________________________________ Contact Please email Lindsey Summers at lsummers(at)pharmascent.com, or call at 303-694-5482.

Medical Writer (Regulatory) San Francisco Bay Area

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Contract position; client only allows W-2 work, and must be on site. Responsibilities

Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety)

Involves working in close partnership with the medical/scientific content owners in the relevant functions

Takes accountability for delivering regulatory documents and works effectively and closely with key content owners

Applies document and project management expertise Contributes to the functional excellence of regulatory documentation (process

management). Prepare regulatory documents in accordance with applicable regulatory guidelines/

standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate

Liaise with document contributors to gather information (including Licensing partners where relevant)

Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate

Resolve issues, errors, or inconsistencies in data with contributors as appropriate Review documents for: organization/clarity/use of English language/grammar/scientific

standards/consistency between textual presentations and listings/tabular or graphical displays

Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments

Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

Obtain and apply knowledge of company and regulatory guidelines, procedures and best practices across relevant documents

Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables

Actively contributes to best practices & continuous improvement within Regulatory Documentation

*****************************************************************

Marci Peister, Executive Recruiter at SciStaff Services, LLC

Method Validation Sr. Analyst opportunity with Fortune 500 company in Emeryville, CA - 3509014

PLEASE READ Due to high volume, individual profiles cannot be reviewed. Please read entire job description below and if qualified, send current WORD copy of your resume to: [email protected] US based candidates ONLY, please NO sponsorship, NO relocation Our client, a global leader in the pharmaceutical industry, is looking for a

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Method Validation Sr. Analyst to work in their Emeryville, CA, location. Scope of Job: Responsible for developing and validating release, in-process and cleaning methods in support of client’s immunodiagnostic products. This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods’ intended use(s) and comply with applicable regulatory and company validation requirements. Responsibilities: • Assist with development and validation of analytical test methods for immunodiagnostic products and intermediates in accordance with ICH/USP requirements and client’s Quality Module guidelines • Write analytical method validation protocols, method validation summary reports, and method development reports • Execute validation protocols and train and provide technical assistance to fellow QC Methods Validation and QC Chemistry team members • Review method development and validation data to ensure completeness and accuracy • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH and client’s Quality Module guidelines • Perform deviation investigations and CAPA implementation in support of method validation projects • Assigned tasks may require standing for up to 7 hours a day, handling chemicals and potentially infectious reagents including HIV and HCV positive serum or plasma samples. May require lifting or moving materials and test equipment during the performance of assigned tasks. Education: Bachelors degree in Chemistry, Biology, or a related field, Required Experience: A minimum of 5 years in a GMP analytical testing environment (Pharmaceutical or Diagnostics/Device industries) • Experience in executing analytical test protocols • Experienced in protein chemistry and immunochemistry methods such as SDS-PAGE, ELISA, reversed phase and size exclusion chromatography, absorbance assays, and Western Blots desirable • Excellent written and communication skills, scientific report writing • Proficiency in MS Word and Excel. Proficiency in other statistical analysis software desired.

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**************************************************** Rebecca Janney, Direct-hire Recruiter at The Clinical Resource Network Director, Business Development opportunity with a global Clinical Research Organization. Company does not currently have any BD presence in the West - email me at [email protected] for details! This is a great opportunity for someone with 5+ years in clinical research BD who would like a very untapped region! Position offers great base salary (and can accommodate more senior professionals) and excellent comp plan. ************************************************** Apply on company website Document Control Manager Coherus Biosciences - Redwood City, California (San Francisco Bay Area) Job Description Title: Document Control Manager Reports to: Sr. Director, Quality Assurance Location: Redwood City, CA Local candidates only. No relocation will be provided. Overview: Oversees and manages the creation and ongoing administration of company documents for all of the company’s GXP related processes.

Responsible for the implementation and ongoing management of Quality procedural and recordkeeping documents

Issue Change Orders for procedural documents undergoing revision Provide support and guidance on procedural processing requirements and expectations

to authors and SMEs Manage approval processing of all procedural documents including formatting and

facilitating approval signatures with Senior Management Resolve questions regarding the Document Control processes Track and follow-up with Authors on Documents in Development (interact with all levels

in the organization) Track and follow-up with Approvers on documents routing for approval signatures

(resolve any questions) Provide monthly tracking metrics for procedural documents as requested Update/Archive/Obsolete older version of procedural documents (both electronic and

hard copies) Maintain official hard copy files (ensure all files are current and compliant with

procedures and processes) Responsible for the converting of hard copy Change Control records and Validation

records to electronic copies and filed in designated electronic locations Assist the Quality team with vendor audits as necessary Participate in document management projects as requested

Desired Skills & Experience BS/BA in life sciences or equivalent is preferred Must have 5-8 years of document control experience in a pharmaceutical or

biotechnology company Must have proven writing, proofing and editing experience Must have outstanding organizational, administrative and attention to detail skills Must have a solid knowledge and understanding of GXP SOPs Experience with vendor audits is preferable Must have great customer and client service skills Excellent interpersonal and communication skills. Strong computer skills, including all MS Office applications Must have the ability to travel domestically for periodic vendor audits, up to 15%

Company Description

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Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information Posted: August 9, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Biotechnology Job ID: 3540156 ************************************************** Ofer Rak, Global Executive Recruiter If the job can be relevant for you or you know someone that might be interested, I will appreciate sending relevant CV compensation expectation directly to me: [email protected] Seeking Executive Global Regulatory Affairs Director for Ophthalmic Surgical Device company in Orange County, California Our client is a leading global provider of eye health products including tools and technology for eye surgeries. Position Summary: The Global Regulatory Affairs Director manages all regulatory aspects of company’s Surgical products throughout their lifecycle. The position covers Equipment, Instruments and Accessories, IOLs, Inserters and Surgical Solutions. The incumbent is responsible for the overarching global surgical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Surgical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and evaluation of changes to product, process, facilities, etc.). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. The position is responsible for regulatory activities related to design, development and US/EU approval. Specific Job Duties Serve as a leadership team member for the company Surgical Regulatory Affairs function Oversee the development of global product regulatory strategies for all the company Surgical products Oversee the regulatory functions in relation to device design & development and product approvals, consistent with the company agreed upon timelines Manage interactions with Regulatory Authorities for Surgical products

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Build relationships with the company regional and global Regulatory Affairs teams Provide regulatory support to other functions in the company (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to internal product review boards Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance Play a significant role in the performance management process and career development programs for supervised regulatory personnel Education & Experience Bachelors degree in science or health related field Advanced degree highly preferred (PhD, MD, MS, JD, or equivalent) 10+ years medical device industry and regulatory experience Ophthalmic Surgical device regulatory experience highly preferred Technical Qualifications Knowledge of ophthalmic surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization Ability to influence and partner within the company Global Regulatory Affairs group and with cross-functional teams Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data **************************************************** Apply on company website Medical Education Manager/Senior Medical Education Manager- IMED Genentech - South San Francisco, CA (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position IMED Planning & Development Stays abreast of the external environment: industry and market trends, regulatory developments, state-of-the-art medical education methodologies, as well as adult learning principles and methodologies. Brings this knowledge to bear in the planning, development, management and oversight of independent medical education grants and programs for the assigned therapeutic areas Works with manager and other team members, as well as a host of cross-functional partners to periodically review Genentech's position, strategy and communication regarding its

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commitments to independent medical education: Uses in-depth expertise of IME and the assigned therapeutic areas to make recommendations for Genentech's IME position, strategy and communication Participates in the development and ongoing maintenance of criteria used to assess appropriate IME providers, such as academic institutions, hospitals, professional societies and associations, as well as for professional medical education organizations Participates in the development and ongoing maintenance of consistent and fully compliant criteria used to assess IME grant requests Contributes to LRP (Long-Range Plan), lifecycle plans, 3-year brand plans, and 1-year tactical plans relevant to the therapeutic areas of assignment Works with partners in Legal, Regulatory, Genentech's Healthcare Compliance Office and Commercial Business Practices, among others, to regularly review and contribute to any updating/enhancement to Genentech's Policies & Procedures regarding independent medical education Develops appropriate and fully compliant IME provider information and communication regarding Genentech's position and commitment to independent medical education Works with manager and other IMED team members to continuously review, fine-tune and hone IMED grant processes, procedures, systems and tools. Includes responsibilities for identifying and recommending IMED program tracking, evaluation, and reporting Works with manager and other internal partners/stakeholders to develop, review and obtain approval for the IMED budget applicable to his/her assigned therapeutic areas Completes special projects such as conducting IME provider surveys, enhancing GRC charters, researching and communicating innovative approaches to independent medical education, etc. 3. IMED Management & Operations At all times, follows pre-established processes, procedures and systems to ensure careful evaluation, meticulous record-keeping, impeccable communications and timely response to grant applications Ensures regular, timely and thorough communication with key internal and external customers and stakeholders; includes regular stakeholder communication on IMED policies & procedures Distributes appropriate communication and information to IME providers relevant to the assigned therapeutic areas For the assigned therapeutic areas, manages all incoming grant requests and assesses for appropriateness and compliance with Genentech criteria, policies and procedures Chairs the GRC for assigned therapeutic areas, which is a cross-functional review group. Updates members on grant status, pending requests and other relevant information Approves grant requests as based on consistent application of Genentech pre-established objectives, criteria, policies and procedures Where appropriate, elevates certain grant requests to his/her manager for further review and assessment Coordinates other requests for non-financial assistance, such as provider requests for supplemental invitation distribution and mailing lists. Collaborates with grant coordinators to ensure triage and timely response to provider requests Hands-off approved IMED grant requests to IMED grants coordinator for further processing Obtains regular status reports from providers for larger-scale activities Requests and ensures external providers conduct assessments of post-program results to assure programs meet pre-determined educational needs At all times, maintains impeccable records regarding the submission, review, approval and issuance of IME grants, as these pertain to his/her assigned therapeutic areas At all times, tracks assigned IMED budget to ensure compliance with pre-established parameters. Completes reporting on IMED budget expenditure Produces other regular and ad hoc reporting for various Genentech internal partners and stakeholders; namely status on grant requests, grant approvals, key medical education programs and the results from such, as relevant to the therapeutic areas of assignment

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Continuously evaluates effectiveness of IME programs for the assigned therapeutic areas; helping to ensure, at all times, compliance with governing laws, regulations and Genentech policies & procedures, as well as appropriate investments Completes other administration, as and when assigned Trains cross-functional areas on IME-related matters and topics Participates in team meetings and other forums. Prepares in advance and provides a specialist perspective/contribution to team and other group developments Who You Are • Bachelors Degree • MBA or other related graduate-level degree is preferred (advanced science or medical degree is a plus) • 4 years' or more previous experience in the pharmaceutical/biotechnology/or other related industry; previous experience in medical education or medical affairs is strongly preferred (CME Professional Certification a plus) • Previous experience in the same or related therapeutic area is strongly preferred. Must demonstrate knowledge of, or aptitude to learn, the relevant disease state(s) • Must demonstrate some previous exposure to medical education; including knowledge of IME providers and their processes, procedures and practices for obtaining IME grants and implementing IME programs • Must demonstrate knowledge of, or the aptitude to learn, the legal and regulatory environment as it relates to medical education in the pharmaceutical/biotechnology industry • Must demonstrate knowledge of, or the aptitude to learn, medical education and adult learning methodologies • Previous experience managing large-scale expense budgets is preferred • Proven track record of meeting or exceeding objectives and goals • Business travel, by air or car, is required for regular internal and external business meetings Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply. Additional Information Posted: July 30, 2012 Type: Full-time Experience: Associate Functions: Management, Other Industries: Biotechnology, Pharmaceuticals Employer Job ID: 00393312 Job ID: 3470711 _______________________________________________ VP, Safety Science Oncology Therapeutic Head Genentech - South San Francisco, CA (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

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The Position Job Purpose: The Head, Safety Sciences, leads and directs one of the therapeutic areas of safety science aligned with the Oncology disease to provide strategic direction and standardization of performance across the Safety Science groups. The Head, Safety Sciences directs Product Development Safety's (PDS) disease area specific scientific analysis including medical evaluation, risk assessment and management, signal prediction/detection, Comparative Benefit Risk, using epidemiology and other input as appropriate. The Head, Safety Sciences will ensure the incorporation of Comparative Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the cluster to ensure their longevity. In general, he/she is a member of a Development Review Committee (DRC). Primary Responsibilities: � Ensure proactive surveillance and monitoring activities across their safety science cluster to ensure that Roche is aware of potential emerging safety issues and has developed strategies & action plans to prevent & mitigate risks. � Direct and manage the SSLs and their teams within the safety science therapeutic area and provide guidance to the relevant development and safety committees as appropriate. � Maintain managerial oversight of issues and outputs from the therapeutic area Safety Teams address or elevate issues to the PDS Global Head, Drug Safety Committee, Lifecycle Teams, Research and Early Development teams, and various committees. � Ensure the incorporation of Comparative Benefit-Risk concepts & qualitative/quantitative methods in the Disease Area (in collaboration with Clinical, Regulatory & Medical Affairs) and their use throughout the development and commercial lifecycle to ensure the safety and longevity of all products in their therapeutic area. � Lead continuous improvement efforts in Safety Science capability and performance together with the other Heads of Safety Science areas. Provide leadership and line management to their reports and other members of the Safety Sciences department across multiple locations. � Build and leverage Roche and PDS’ influence with internal and external entities to create value for Roche. � Ensure Collaborative and constructive business relationships with major partners where applicable (with particular interest in Chugai). Ensure particular emphasis is placed on communication flow and inter company. � Contributes as part of the Global Leadership Team to the overall management of the Safety Risk Management Department. � Partners with Clinical Development organization to facilitate and collaborate towards the development of new oncology products proactively. Build strategic relationships with Clinical Development Oncology to drive innovative trial designs and influence decision-making. Who You Are Education/Qualifications: Minimum: � MD with a specialty (Internal Medicine, Pediatrics, Geriatrics, or other relevant to the disease are specialty). An additional degree (e.g. PhD, MBA, MSc, MPH) is a plus, � 5 years clinical practice required � 3-5 years pharmaceutical/biotech industry clinical drug development experience desired Experience, Skills, Knowledge � Significant clinical experience in treating patients and significant experience in pharmaceutical industry (clinical development, drug safety, medical affairs)

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� Previous experience at a management level in drug safety, clinical development or medical affairs, including in the evaluation and interpretation of scientific and clinical data. Credible knowledge of Safety Science across a breadth of therapeutic areas. � Demonstrated experience of managing global pharmacovigilance activities, particularly in relation to issue management and signal prediction, detection and evaluation. � Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations � Solid knowledge of Asian pharmacovigilance regulatory requirements and general regulatory expectations is a plus � Proven experience in managing a team of individuals located across a number of sites and in leading them to optimize their performance and contribution. Proven ability to coach and develop people � Strong negotiation skills � Strong written and verbal communication skills to a variety of levels and teams. Demonstrated persuasion and influence skills � Ability to operate objectively and independently as a leader and as a member of a team, as required � Proven ability to manage budget and timelines � Ability to interact with high level officials in Health Authorities and other policy makers � Willingness to undertake significant travel internationally � Ability to work effectively across cultures and in virtual environment Additional Information: � The Head, Safety Science Oncology could be a member of the Drug Safety Committee. � Associate Safety Science Oncology Heads will report into this role from various sites. � When necessary, the Head of a Safety Science may also be the site Head for all Safety Science staff on the site Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply. Additional Information Posted: July 26, 2012 Type: Full-time Experience: Executive Functions: Other Industries: Biotechnology, Pharmaceuticals Employer Job ID: 00384462 Job ID: 3456026 **************************************************** Senior Market Research Manager Actelion - South San Francisco (San Francisco Bay Area) Job Description POSITION SUMMARY The Senior Market Research Manager will lead the market planning and market research strategies for all marketed brands in the US, with a particular focus on the Pulmonary Arterial Hypertension (PAH) portfolio, in order to facilitate the successful execution of Actelion Pharmaceuticals U.S. commercial objectives. The Sr. Manager will execute high quality studies that generate actionable business insights and support strategic decision making for the brands. This position is responsible for all local level market research studies and will collaborate with the Global team for Global market research studies.

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PRIMARY RESPONSIBILITIES include the following. Other duties may be assigned Engage internal departments to understand market research needs and conduct

quantitative and qualitative market research aimed at such topics as patient flow, Attitude, Trial, and Usage (ATU) tracking, positioning, message recall, segmentation and perceptual mapping.

Leverage product and market knowledge to understand key business questions and issues and to design and execute high quality studies.

Develop ad hoc projects as needed to test appropriate market variables. Collaborate cross functionally to ensure best outcome to research projects. Construct and present findings from market research to brand teams and senior

management as actionable business insights. Support strategic decision making through incorporation of marketplace information

into business plans and forecasting. Interface with our Global counterparts to ensure alignment in activities, methodology,

and insights. Select, train, and manage market research vendors.

Desired Skills & Experience BA/BS/MS/MA in an analytical field with a strong academic record or equivalent. Minimum of 5 years of pharmaceutical or analytical consulting work experience with

exposure to both primary and secondary market research methods Expertise in data management tools (e.g., Excel) as well as Word and PowerPoint. Experience analyzing secondary data in the pharmaceutical industry (IMS, WK) a plus. Adept at summarizing analytical information and translating it into simple language Must be skilled at multi-tasking, problem solving, project management and working in a

fast environment Able to prepare and present clear and concise reports Communication skills should allow candidate to succinctly and accurately present top-

line conclusions from market research to all types of audiences Great relationship-building abilities and ability to work cross-functionally

Actelion provides equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability and all other protected categories. EEO Company Description Actelion Pharmaceuticals Ltd is a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, focusing on the discovery, development and commercialization of innovative treatments to serve high unmet medical needs. Actelion was founded on 17 December 1997 and is now a public listed company on the Swiss stock exchange (SIX). Additional Information Posted: August 8, 2012 Type: Full-time Experience: Mid-Senior level Functions: Other Industries: Pharmaceuticals Job ID: 3364166 Veteran Commitment

Actelion commits to hiring returning veterans.

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**************************************************** Apply on company website Senior Manager/Manager, Medical Education Vivus Inc - Mountain View, CA (San Francisco Bay Area) Job Description Responsible for leading Key Customer brand marketing and driving KOL strategy and tactical execution. Responsible for interpreting insights from key customers to help differentiate the brand, and ensure a successful product launch. This includes providing strategic direction and leadership as well as managing the execution of projects within tight deadlines. One primary focus will be on peer-to-peer programming, including development and execution. Other medical education responsibilities such as advisory boards and KOL planning are also critical priorities. Key responsibilities include:

Lead in the development and execution of peer-to-peer programming and tactics Lead in the development of physician or other HCP advisory boards. With team, manage medical commuications and services agency(s), including

determination of services and budget management required to successfully launch a new product/brand.

Collaborate with medical affairs and sales leadership to develop and execute key opinion leader focused initiatives.

Collaborate with Health Systems Marketing team to deliver pharmacy tactics. Develop deep insights into customer behaviors that allow Vivus to tailor programs and

messages to meet the unique needs of the institution. Desired Skills & Experience

Bachelor’s degree, MBA preferred, in economics, business or life sciences 5+ years of pharmaceutical or biotech industry experience with focus on marketing,

including development of market strategies and execution of tactics at the brand or segment level. Product launch experience desired

Minimum of 2 years of experience in sales, sales operations, or sales training preferred. Strong leadership skills, presentation skills, innovative thinker, business minded, ability

to adapt strategies to evolving pharmaceutical regulations Strong interpersonal skills with the ability to collaborate and work effectively in a small

cross-functional team environment Strong agency management experience Strong project management experience and attention to detail Demonstrated ability to drive for results

Company Description At VIVUS we believe that high quality people produce high quality results. If you are passionate about making a difference in people's lives and enjoy working with a smart and talented team, VIVUS might be the place for you. We cultivate an environment where you can fulfill your personal goals and at the same time, you are working for a company that's making a difference in the lives of people. VIVUS is committed to equal employment opportunity. We do not discriminate against employees or applicants on any legally-recognized basis including, but not limited to: veteran status, race, color, sex, religion, marital status, national origin, physical or mental disability, age, sexual orientation, medical condition, pregnancy, childbirth or related medical condition, political activity and ancestry. Additional Information Posted: August 6, 2012 Type: Full-time Experience: Mid-Senior level Functions: Marketing Industries: Biotechnology

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Job ID: 3510589 ************************************************* Please email [email protected] for immediate consideration.

Joy Celebre Retained Medical Device Recruiter/General Manager

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**************************************************** http://www.collabera.com/about_us/accolades.jsp Software Engineer Collabera - Santa Clara (San Francisco Bay Area) Job Description

LEGACY MEDSearch Emerging Medical Technology Recruitment Phone: 407-898-4440 ext. 104 Marketing Manager | Medical Device | Orthopedic Trauma | Capital Equipment Industry leading company is seeking a Marketing Product Manager with surgery-based experience in medical device capital equipment surgical marketing and product launch, to develop and execute marketing plans and programs to successfully launch products and expansions planned within the next 4 years. Position Requirements

4 -10 years of medical device marketing at the Marketing Manager level with leading orthopedic, neurosurgery, or operating based medical device companies. Surgical Capital equipment experience is strongly preferred,

Knowledge of Clinical Marketing within an acute care setting, to include the surgical operating room or cath lab environment and the ability to develop a comprehensive strategic marketing plan to include measurable metrics, objectives, goals, strategies, tactics, in-depth competitive market/product analysis, and timetable.

Experience performing market trends/analysis, product pricing and promotion including product launches and product distribution.

Ability and willingness up to travel 40%. Education Requirements

Bachelors degree in Business, Engineering, Marketing, Life Science or similar MBA or Masters degree in Marketing, Project Management or similar preferred (not

required) Primary Responsibilities

Develop, plan and implement product launches and product distribution. Interface with advertising agency to provide advertising with core brand equity, develop

product/market awareness campaigns, and coordinate all key trade show marketing inputs. Ensure all marketing materials meet company approved branding and trademark guidelines, and obtain final approval from the appropriate departments.

Identify issues from the field, competitive updates, and physician champions and act on feedback to drive product adoption.

Developing a marketing budget and forecast relating to assigned product portfolio, conventions and meetings, advertising/promotions, literature, etc.

Train current and newly hired sales employees on marketing strategy, sales support materials, and key marketing programs.

Work closely with key surgeons and product development to define market and product requirements for new products/markets needed to further enable key surgical procedures and drive procedure adoption.

Responsible for the evaluation of pricing/profitability of the assigned product portfolio, and for making recommendations for changes with justification, where required to meet the corporate goals. Submit price changes for approval by Director Marketing.

Attend and report to all meetings in assigned product/market area. Interface with RA/QA Department where appropriate regarding product complaints and

coordinate resolution and ensure that product line is in compliance with the FDA. Please email [email protected] for immediate consideration.

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Seeking a creative software engineer to perform design, implementation, and unit testing of software subsystems. This person will direct a team through the implementation and unit testing of large subsystems. The interface subsystems are based on Sammi, a Motif interpreter. This individual will be responsible for interface designs to support the Sammi windows. Will use a C++ standard template library to take high level designs into software implementation. Requires a bachelor's degree in a related area and 7+ years experience in the field or related area. Desired Skills & Experience Candidates with 5-8 years of development USER interfaces strong in C#, WPF, WCF. Strong objective oriented and UML skills, experience with relational databases. Good oral and written communication skills. LIKE TO HAVE - Experience w/developing SW for Medical Devices Experience in Agile/Scrum environment Experience w/Expression Blend is a strong plus Experience w/LLBLGenPro, NUnit Image Processing Company Description Why to Join Collabera Family !!! Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a Half a million $ IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to succeed in an increasingly competitive marketplace. With over 5000 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.

Collabera listed in GS 100 - recognized for excellence and maturity Collabera named among the Top 500 Diversity Owned Businesses Collabera listed in GS 100 & ranked among top 10 service providers Collabera was ranked:

o 32 in the Top 100 Large Businesses in the U.S o 18 in Top 500 Diversity Owned Businesses in the U.S o 3 in the Top 100 Diversity Owned Businesses in New Jersey o 3 in the Top 100 Privately-held Businesses in New Jersey o 66th on FinTech 100 o 35th among top private companies in New Jersey

To know more about Collabera, please visit us on www.collabera.com. I look forward to working with you. Additional Information Posted: August 16, 2012 Type: Full-time Experience: Mid-Senior level Functions: Information Technology, Quality Assurance Industries: Biotechnology, Medical Devices, Pharmaceuticals Job ID: 3579031 ******************************************************

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Apply on company website See list of company openings at http://www.linkedin.com/company/402048/careers?trk=NUS_CMPY_FOL-job Director of Corporate Compliance Veeva Systems - Pleasanton (San Francisco Bay Area) Job Description Veeva Systems, the leading provider of SaaS based applications to the pharmaceuticals and life sciences industries, is seeking a seasoned compliance professional to join our fast growing, agile team. The Director of Corporate Compliance will work closely with our internal business and technology teams in the development, implementation and ongoing management of the company’s compliance program in a manner consistent with industry best practices. Reporting to the VP of Operations, this highly visible position is responsible for managing the corporate compliance team, the development and delivery of training, policies, and SOPs, managing internal, external, and customer audit programs, and the reporting of compliance status to senior management. If you’re interested in making a global impact at a pre-IPO company, this is the opportunity you’ve been waiting for. . Responsibilities:

Manage internal compliance team Maintain GxP compliant policy/procedures Maintain 21 CFR Part 11 validated environment for all products Responsible for Quality Management System, Management reporting Implement, manage, and maintain CAPA system Manage corporate training program Manage customer audit policy/procedures Manage external audit policy/vendor audits for IT/Operations (SOC2, S-Ox) Keep up to date on data security/privacy laws and update policy/procedures to support

Desired Skills & Experience Requirements:

Bachelor's or advanced degree Managed a team of 3 or more people for 2 or more years Hired at least 1 person in the last 2 years Worked in the compliance/internal audit area of a technology company (software or

hardware) selling into a regulated industry (preferably pharmaceuticals, life sciences, or similar)

Has participated in at least 20 customer audits Work location Pleasanton

Nice to Have: Demonstrated experience in any of the following areas: Implementation / maintenance of Corporate Quality Policies, Procedures / SOP's Risk assessment GxP / 21 CFR Part 11 compliance Computerized Systems Validations Internal audit - (IT/IS systems, security, change controls, data center, disaster

recovery) External audit - (vendor assessment) CAPA Quality Management Systems Data privacy / Information Security Certifications (CQA, CQM, CISA) a plus

Company Description

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Veeva Systems is the leader in SaaS business solutions delivered in the cloud for the global Life Sciences industry. We’re rapidly growing, profitable, pre-IPO company with over 150 customers and a 300+ employees worldwide. Our product teams are based mostly in Pleasanton, CA and San Francisco, CA. Veeva was named to the Red Herring 'Top 100' software companies for North America in 2011. Founded in 2007, Veeva is headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Beijing, Shanghai, and Tokyo. For more information, visit www.veevasystems.com Additional Information Posted: August 16, 2012 Type: Full-time Experience: Not Applicable Functions: Quality Assurance, Information Technology, Consulting Industries: Computer Software, Information Technology and Services Job ID: 3579940 ******************************************************

Katie Lepper, ACIR, CIR, CDR, CSSR, Recruiter at The RightThing, An ADP Company [email protected]

Now Hiring!

Lundbeck is hiring world class Psychiatry Sales Account Managers to help shape our growing sales force! (SAN JOSE, STOCKTON, SACRAMENTO, BAKERSFIELD & SANTA BARBARA, CALIFORNIA) Please contact me for details!

************************************************** Apply on company website Director Financial Planning and Analysis Pharmacyclics - San Francisco Bay Area Job Description Responsible for the overall Budgeting, Forecasting and Planning activities of the company as well as supporting Strategic Analysis and Pricing. Coordination and accountability for the company’s Long term Planning process and Annual Budget which includes cash management & profit planning, forecasts, expense budgets, clinical trial forecasting, accounts receivable, cost standards, saving opportunities, and capital investments. The position is a key position reporting to the EVP Finance & Accounting responsible for the long and short-term forecasting and budgeting, alliance financial management, internal financial reporting, financial analysis, Budget vs. Actual, variance analysis, Financial Systems implementation and management, and communication of financial results and key performance metrics.

Manage all financial planning and analysis activities for the business, including clinical trial forecasting and budgeting

Lead the annual planning/budgeting process by directing other financial analysts and consolidating results

Manage the compilation of the budget and present analysis of budgeted amounts to actual results and forecasts on Monthly/ Quarterly basis. Manage the forecasting analysis through identifying, understanding and communicating changes. Consolidate and develop variance commentary

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Development of monthly/quarterly management and Board of Directors (BOD) reports regarding the underlying performance of the businesses, leading indicators and key metrics

Analysis of quarterly results to facilitate discussions with senior management related to earnings release and to facilitate the preparation of MD&A and other analysis

Establish and maintain partnership with other functions including Accounting, Benefits, HR, Financial Reporting, Tax, and Treasury

Implementing and managing financial systems, business intelligence tools, clinical trial modeling and financial planning best practices

Play a key role in integrating the reporting and planning process for worldwide subsidiaries.

Lead the annual long-term planning and modeling process. Building strategic long-term financial models to facilitate analysis and decision-making including operating targets, proposed business cases, capital budgeting and other strategic opportunities

Provide ongoing analysis of financial performance including analytical support for external documents, peer comparisons and valuation

Identification, development and maintenance of key operating metrics and dash boards for internal reporting

Create and provide analytical support for presentation materials, including Board meeting discussion materials and presentations

Effective communication of financial results and key operating metrics to internal teams Perform and provide analysis related to product development, profitability and capital

spending justification Develop/analyze business cases using various financial methods Perform variety of tasks and ad-hoc analysis, as necessary

Desired Skills & Experience Bachelors Degree in Accounting or Finance is required; Masters Degree is preferred Minimum 8-10 years experience with increasing responsibility of management positions

within Finance/Accounting areas. Minimum 3 years’ experience as Manager and/or Director FP&A. Must have expert level skills in Microsoft Excel, Word, PowerPoint and Access as well as

other applications. Experience with ERP systems, and document retention solutions. Experience with SAP

Business One and or Cognos, Hyperion, R3 is preferred. Develop performance measurement standards. Participates in staff performance related

issues and periodic appraisals. Report performance results based on key metrics. Develop and conduct training programs for employees. Coach uses of software to

assure features are maximized. Company Description Pharmacyclics Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are synthetic small-molecules designed to target key biochemical pathways involved in human diseases with critical unmet needs. Additional Information Posted: August 15, 2012 Type: Full-time Experience: Mid-Senior level Functions: Finance Industries: Biotechnology Job ID: 3572853 *****************************************************

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Apply on company website Environment Health and Safety Manager Pharmacyclics - San Francisco Bay Area Job Description The Environmental Health and Safety Manager will be responsible for the day to day maintenance/execution, improvement and/or implementation of environmental, industrial, health and safety programs within the company. Develops health and safety policies and procedures (chemical and biological safety, radiation safety, hazardous waste management, ergonomics, illness and injury prevention and building safety), including those pertaining to hazardous materials and work areas. May oversee compliance training and inspect laboratory and office areas to ensure compliance with occupational safety and health standards. Monitors performance of Environmental Health and Safety programs and regulatory compliance with all regulations, and handles all contact with compliance inspectors from government agencies. The selected individual will be responsible for the following efforts:

Establish, maintain and manage a safe work environment by enforcing safety policies and regulations, reviewing procedures for safety concerns, and participating in project reviews. Is the principal site representative for all EH&S matters

Manages and oversees all internal safety activities, interactions with government agencies, professional EH&S groups, and community advisory panels

Develop, implement and manage EH&S programs and initiatives to meet regulatory requirements and EH&S needs of the site

Review and oversee all work processes and conditions to ensure EH&S protective measures are optimized. Develop, recommend preventative and improvement measures to ensure the enhancement of EH&S

Ensures compliance to environmental and safety standards through inspections of operating areas, audits, operation readiness reviews and through review and approval of operating procedures

Advise and actively participate in risk and hazard evaluations for EH&S reviews of existing processes, equipment and all new capital investments.

Provide timely resolution of safety problems by defining the problem, determining root cause, establishing action plans and priorities, expediting repair and providing technical assistance.

Promote safety consciousness among employees by providing accurate and informative data, conducting safety meetings, giving timely feedback, on safety suggestions and visibly supporting the plant safety program.

Select, train and lead First Alert Team to address potential emergency situations. Desired Skills & Experience

Bachelor’s degree in safety, environmental management, and/or sustainability engineering discipline.

Masters degree in engineering or science a plus. Requires a minimum of 5 to 8 years of hands-on experience in an environmental,

health, safety, and sustainability related discipline and technical/practical knowledge of EHS+S regulations, codes, and guidelines (Must have thorough knowledge of federal, state and local EHS regulations, including OSHA and EPA. Professional certification: CSP, CIH, or other certifications a plus.).

Demonstrated ability to recognize, evaluate, and recommend controls for workplace hazards.

Demonstrated ability to determine training needs, organize and/or conduct training. Strong interpersonal and communication skills required, including the ability to interact with outside regulatory agencies.

Demonstrated proficiency with computer applications, including word processing, spreadsheet, and slide presentations required.

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Technical and practical knowledge of biotechnology, research and development and/or manufacturing is highly recommended, or a willingness to quickly become proficient is required.

Company Description Pharmacyclics Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are synthetic small-molecules designed to target key biochemical pathways involved in human diseases with critical unmet needs. Additional Information Posted: August 15, 2012 Type: Full-time Experience: Mid-Senior level Functions: Other Industries: Biotechnology Job ID: 3572871 ******************************************************* Posted by Cheryl Ward, CIR, Executive Recruiter at SciStaff Services, LLC If you meet the above requirements, please forward a copy of your resume (word format)to [email protected] for confidential review.

State: California City: Redwood City ZIP: 94063

Job type: Full-time Company Name: SciStaff Services Job Description: Our client is seeking a Clinical Medical Writer to work out of Redwood City, CA for approximately 6 months. This individual will prepare technical documents to support both domestic and international regulatory submissions. He/she will incorporate text, graphs, charts, tables and statistical analysis, and proofread, circulate, edit, assemble and inspect product submissions. Qualified candidates will have an advanced degree AND a minimum 5 years of industry experience. US based candidates ONLY, please - NO sponsorship, NO relocation ******************************************************* Contact Leslie Berger, VP Legal and Executive Recruiting at Soar Staffing, LLC [email protected] Looking for an experienced Medical Affairs Director for a young, dynamic Electrophysiology company based in California. Great opportunity. Medical degree preferred. *******************************************************

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To apply for a position send your resume to [email protected]

Manager, Regulatory Affairs - Full Time Position (San Francisco Bay Area) PPBI

To view this position and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: • Prepare, manage, and submit FDA (510(k), IDE, PMA) and European submissions for approval and ensure compliance with all U.S. and international regulatory requirements. • Capable of communicating regulatory strategies to project team members and provide regulatory guidance as necessary. • Communicate directly with regulatory agencies including the notified body and FDA. • Share responsibility in communicating with senior management, providing highlights and updates on status of projects as necessary. • Responsible for product labeling, supporting project teams, compiling regulatory submissions, and providing guidance on advertisement and promotional materials. • Responsible for providing regulatory support for Operations and/or Product Development projects and will develop global regulatory strategies. • Oversee product labeling, such as Instructions for Use and device labels, and will provide guidance on the review of advertisement and promotional materials to ensure compliance. • Review and approve design and manufacturing changes and test protocols and reports to ensure compliance with applicable regulations and filing requirements. EXPERIENCE AND QUALIFICATIONS: • A minimum of a Bachelor's degree plus a minimum of 5 years of Regulatory experience with medical devices is required. • Experience with all three classes of medical devices is preferred (I, II and III). • Exhibit knowledge of FDA regulations for medical devices and have experience writing FDA submissions and communicating with CDRH. • Experience working with CDER and OCP is considered a plus. • A basic understanding of sinus disease and treatments is a plus. • Require excellent presentation skills. • Must be detail-oriented, work well with a team, exhibit initiative and be passionate about their job. • Experience working cross-functionally with R&D, Marketing, and Compliance Copy Review experience is preferred. • It is required to be motivated and a self-starter who can work independently once projects are assigned. It is required to be proficient in Microsoft Word, Excel and PowerPoint. • A Regulatory certification such as RAPS is a plus. • This position may require up to 10% travel. ___________________________________________________________

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To apply for a position send your resume to [email protected]

Technical Recruiter / Sourcing Specialist – Part time permanent position (15-32 hr/wk) San Francisco Bay area PPBI

To view this position and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: • Primary responsibilities are to source open positions with qualified candidates • Document/track recruiting activities in candidate tracking system. • Source, screen and interview candidates EXPERIENCE AND QUALIFICATIONS: • Must have minimum of 4 years of solid recruiting experience. • Experience must be with Pharma, diagnostics or medical devices companies. • Experience in the following areas preferred: Clinical, Manufacturing (CMC), and Drug Development positions • Prior experience making cold calls • Must be self-motivated, present well and be able to develop relationships with candidates. • Ability to navigate through change and demonstrate flexibility as organizational needs shift. • Excellent organizational skills and the ability to work independently is very important • Must develop and implement creative sourcing strategies to identify talent. • Bachelor degree required

**************************************************

For immediate and confidential consideration please forward your resume along with salary history. Marcia Lederman, Executive Recruiter New Career Personnel [email protected], 973-884-1920 http://www.linkedin.com/pub/marcia-lederman/3/964/63aSan Francisco pharma ad agency needs your talent...relo assistance included.

If you have pharma ad agency experience at a senior level and are interested in becoming part of an expanding shop, this is the place for you (if you have oncology experience!!). Account Group Supervisor or Management Supervisor level so your skills must be well honed. Manage client/agency relationships with designated account(s) and the client services team assigned to those account(s). You will ensure your clients continually receive superior service, thinking and quality from the agency and that strategy, planning, programs, tactics, budgets, schedules, creative, documentation and account profitability stay on track. Set an example for junior staffers and foster a culture of excellence in service, thinking and execution. You must have the ability to understand data and analyses and use both to grow brands. Salary in the $160-200K range depending upon experience level. Excellent benefits include bonus eligible, relocation assistance, etc.

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Director Medical Affairs (MD Required) BRecruiting, Inc - Bay Area – Peninsula (San Francisco Bay Area) Job Description Are you an MD who is interested in Medical Affairs? Do you have 4 years of previous Pharma experience? Have you always wanted to get into Medical affairs but never found the right opportunity? Are you outside of the bay area and always wanted to come to CA? (Relocation assistance is offered for the right candidate) Well, look no further. We are currently conducting a confidential search for Medical Director of Medical Affairs for our client in the bay area (CA). Our client is on the verge of huge success. With commercial products and multiple trials in Phase II and III – the future is bright for our client. Main responsibilities are broken into 5 major categories: Provide day-to-day clinical and medical guidance while working closely on joint projects with the medical affairs team and broader organization; projects include medical affairs studies, scientific congress/conference strategy and planning, advisory boards, medical education grant review, publications, field force training, medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects Collaborate with the medical affairs team comprising Medical Communications, Publication Planning, Medical Information, HEOR/epidemiology, MSLs, and Clinical Nurse Educators in the preparation for the commercialization of our clients drug Collaborate with thought leaders to develop clinical therapeutic concepts that warrant additional study, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support the scientific and medical affairs plan for our clients drug. Collaborate with Clinical Development in the strategic planning, management, and execution of Phase IIIB and Phase IV trials. Manage the Investigator Initiated Sponsored Trials review and grant process Collaborate with and provide scientific and clinical support and training for internal departments, including Marketing, Sales, MSL, Clinical Ops, Research, Corp Development, Govt Policy, and IR. Also, external audiences, such as patient advocacy groups, other physicians, other health care providers, formulary and clinical guidelines decision makers. Desired Skills & Experience Requirements:

MD degree Minimum of 4 years in biopharmaceutical medical affairs and/or clinical development

role Demonstrated acumen in presenting clinical and pre-clinical data to external audience

and senior management required Experience with post marketing Phase IV and Investigator initiated studies Experience with product launch preferred Strong leadership, team building, negotiation and ability to execute Exceptional verbal and written communication skills

(**Relocation assistance is offered for the right candidate) Bay Area – Peninsula Company Description BRecruiting, Inc What Is Your Recruiting Strategy, and is it the Right One? Few things are more important to a company’s long-term performance than choosing the right employees and ensuring they have the proper outlook from day one.

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BRecruiting works with clients to develop outstanding Staffing & HR Solutions: solutions that maximize results and minimize investment. BRecruiting can propel your organization, be it large or small, to new levels. You'll experience tangible, positive outcomes from working with our processes and with BRecruiting. We’re passionate about what we do and are genuinely interested in your long-term business success. We ask questions, listen to you and offer ideas and solutions for the unique challenges confronting your organization. Working with BRecruiting will ensure you’ve got the right recruiting strategy in place creating the results your company/organization deserves. All while reducing costs and eliminating risk. The answer to this one question can help you hire the best talent, lower your cost per hire and reduce turnover. BRecruiting has successfully executed recruiting strategies and offered HR solutions for the last 10 years. We have been working with a verity of clients (small & large) with a recent focus on the pharmaceutical industry. Additional Information Posted: August 6, 2012 Type: Full-time Experience: Director Functions: Consulting Industries: Pharmaceuticals, Biotechnology Compensation: DOE Job ID: 3512579 **********************************************************************

Dustin Pritchard 858.427.3668, Staffing Specialist at Simply Biotech

http://bull.hn/l/Q6EC/3

Full Time Direct Hire opportunity for a Polymer Chemist in Irvine, CA. Required: B.S., 4+ years pharma, med device, dental experience, experience designing and running experiments to test ...

Hiring a POLYMER CHEMIST in Irvine, CA POLYMER CHEMIST Simply Biotech specializes in recruiting exclusively for Southern California?s biotech and device community. We are currently seeking a Polymer Chemist for a growing Orange County firm. The Polymer Chemist will lead the development and testing program for new polymer materials for medical device implants Other responsibilities include: * Design and development of sterile injectable, polymer from pre-clinical development through product commercialization. * Develop and execute formulation strategies related to product development, experimental design, data evaluation, generation of scientific reports, and coordination studies with other

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technical groups. * Excellent leadership, teamwork and organizational skills. * Responsible for the development and evaluation of proposed formulations, processing, compounding procedures, and selection of container/closure systems. * Design studies related to the formulation of polymer that may impact the stability and delivery of the product. * Conducts literature searches to support formulation development, pilot manufacturing documentation, and regulatory submissions. * Investigates, troubleshoots and resolves issues associated with formulation studies and/or R D pilot manufacturing. * Collaborates with R&D, Manufacturing, Quality, Microbiology, Validation, and QA departments to coordinate pilot and commercial batch manufacturing. * Demonstrate the ability to provide technical procedure/direction and interact professionally and effectively with senior management, peers, team members, supervisors, outside customers, and other teams/departments on an ongoing basis to ensure product development success. Document all work according to GMP and SOPs The qualified Polymer Chemist will possess the following: . * BS Candidates with 4+ years of directly relevant experience in pharmaceutical, medical, or dental industry * Masters or PhD strongly preferred * Experience with design of experiments, protocol creation, statistics, and unique technologies is highly desired * Experience with polymer development and characterization is also a plus

**************************************************** Contact Charley Lyons, Sales and Recruiting Manager for the Compass Consulting Group Compass Consulting Group Inc. Trumark Building 4185 Blackhawk Plaza Circle, Suite 220 Danville, CA, 94506 Phone number for Brett Forrest, Managing Partner, at (925) 788-8302 Senior Analyst / Manager - Market Access Marketing - Perm/FT role with a Biotech in the San Francisco Bay area. The Market Access Marketing candidate will possess five plus years of healthcare, biopharma and/or medical device industry experience, two years of managed care strategy and payer marketing, and some background in account management and/or reimbursement. Responsibilities include developing payer and channel strategy, marketing plans, tactics, and recommendations to sales and management groups. Payer marketing experience required! Contact me for more information, thanks! ************************************************* Apply company website Paralegal / Administrative Assistant Coherus Biosciences - Redwood City, California (San Francisco Bay Area) Job Description

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Position: Paralegal / Administrative Assistant Reports to: Vice President, Finance & Administration Location: Redwood Shores, California This position will support the company’s legal, business and corporate administration departments.

Work closely with the Company’s legal consultant, Chief Business Officer and VP, Finance & Administration in the preparation/organization of corporate legal documentation and contract management

Create and manage a contracts database; organize and track legal files, contracts, records, and other documentation.

Manage straightforward contract negotiations (i.e. NDAs, etc.); Research various legal issues and analyze legal documents

Work closely with others within the company during corporate transactions, negotiations, or due diligence

Assist the Chief Business Officer with completion of administrative tasks and travel as necessary.

Manage other assignments as requested Desired Skills & Experience

BA/BS or equivalent or a Paralegal Certificate; 5+ years’ experience as a Paralegal within a corporate legal team or law firm

Must have strong administrative skills and a positive, “can-do” attitude Must have basic contract drafting/negotiation experience and familiarity with basic legal

terminology, principles and documentation Must have the ability to prioritize in a fast paced environment, functioning well both

independently as well as on a team Must have an analytical mindset with attention to detail Excellent interpersonal and communication skills. Strong computer skills, particularly PowerPoint and all MS Office applications.

Company Description Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information Posted: August 14, 2012 Type: Full-time Experience: Mid-Senior level Functions: Legal Industries: Biotechnology Job ID: 3564773 *************************************************

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Clinical Contract Specialist Advanced Clinical - San Francisco Bay Area Job Description Outsourcing responsibilities: • Manage, with minimal supervision, the vendor selection process, including the selection of preferred vendor, for designated programs or vendor types. • Perform ongoing project-wide or functional support outsourcing needs analysis for current and future studies Support clinical teams and key internal stakeholders in the generation of specifications for work to be outsourced; determine candidate vendors based on capabilities, capacity, strategic fit, expertise, quality, performance and price. • Contribute to RFP content and process, compile and prioritize selection criteria/requirements, and facilitate decision process to ensure objectivity and adherence to selection criteria. • Review vendor proposal and conduct bid evaluation analyses • Follow mechanisms for management of relationships, performance and stakeholders in regard to outsourced work. • Monitor and reconcile vendor budget against invoices, accruals and contract. • Provide detailed oversight of scope management, ensure that any contractual changes in scope are anticipated by both parties, agreed and well understood, and transparently proportional to actual activity or incurred cost. • Collaborate with GCP Compliance to ensure coordination of vendor audits and relevant follow up activities. • Ensure that industry best practices and departmental SOPs are thoroughly observed Contract responsibilities: • Identify contract needs across Clinical Development and liaise with internal stakeholders to develop appropriate Agreements. • Review, analyze, and negotiate scopes of work, exhibits, budgets, payment schedules to be included as contract attachments. • Coordinate the contract terms/conditions review and negotiation process with external and internal stakeholders and act as the central point of contact through execution. • Collaborate with the Legal and Finance groups to ensure the best contractual structure and terms relative to the services being provided. • Prioritize contract needs across studies/programs and Clinical Development departments and ensure timely processing of contracts. • Oversee financial approvals process in accordance with Company policies. • Manage changes in contract scope, change orders, and amendments to ensure accurate and timely revisions to terms and/or services. • Monitor and reconcile vendor budget against invoices, accruals and contract, as needed. • Develop and implement metrics to track contract status and process performance. General responsibilities: • Lead and/or assist in Clinical Outsourcing projects, as applicable/appropriate. • Record information in tracking tools to ensure completion of assigned activities. • Prepare professional and accurate communication with internal and external stakeholders. • Evaluate existing processes and lead process improvements related to contracts and budgets. • Participate in the review of relevant department SOPs to ensure accuracy. • Participate in team meetings and other forums. • Incorporate best practices into discussions with clinical teams and preferred providers. Desired Skills & Experience

1. Two years of Outsourcing experience, either as an outsourcing specialist or analyst. 2. Experience with:

1. Vendor Management 2. Negotiations with Vendors 3. RFP/RFI

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4. Change orders and Change order Management 3. MBA or BA in Finance or a Pharma related field

Company Description With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, creating a positive, sustainable impact for our clients in the Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device industries. We utilize a value-based approach, “One Team” client partnering model, proven tools and methodology and our experience for a proactive, collaborative and innovative approach to client solutions. Advanced Clinical understands the modern challenges facing the Life Sciences industry. To improve our ability to help clients, we channeled our expertise and performed intense research for a year to develop a groundbreaking, new approach to all aspects of the “Business of R&D.” We pulled the leading practices from all other industries, in areas such as risk management, project management and collaborative planning, to allow us to accelerate clinical trials at lowest total cost of ownership (TCO) and highest probability of success with robust quality, safety and efficacy. We have codified our research into the “Industry Leading R&D Performance” (ILRDP) framework, which contains tools, methods and practices, creating a business that is better than “best in class,” with our leading practices from all industry segments. The new ILRDP framework creates breakthrough value for our clients and consultants. Additional Information Posted: August 14, 2012 Type: Contract Experience: Associate Functions: Other Industries: Biotechnology Referral Bonus: Up to $2000 Job ID: 3564969 ********************************************** Apply at http://www.ziprecruiter.com/job/HR-Business-Partner-Manager-Sr-Manager-Human-Resources/a7b7049c/?goback=.gde_48201_member_146614313 HR Manager/Sr. Manager - Veracyte South San Francisco Manager/Sr. Manager, Human Resources ziprecruiter.com Job Description: The Human Resource Manager/Sr. Manager will function as a front-line HR Business Partner responsible for Employee Relations, Project and Program Management and some Recruiting (~30% of total workload). This individual will collaborate with managers to diagnose and solve business challenges related to achieving objectives, improving performance, optimizing organizational effectiveness, assessing allocation of talent resources and full cycle recruiting for talent gaps. The ideal candidate will possess recent and demonstrated ability to:

Consult with managers to work through Employee Relations issues to ensure a positive and individualized approach to resolution

Recognize, analyze and diagnose key trends in talent management and ER metrics to uncover root causes. Develop and design solutions, using root cause analysis to influence change

Act as the point person for employees; provide coaching and a focus on solutions Provide a balance between being a coach to employees and management; takes a

consultative approach acting as an impartial Company representative Participate in the development and roll out of HR programs (performance management,

compensation, reward and recognition. workforce planning etc.) Identify trends in the external marketplace for attracting the best talent through

ongoing research and networking efforts

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Ensure a talent acquisition strategy map is available for key positions based on market conditions; taking into consideration local and national availability of candidates

Use innovative techniques to source passive and active candidates. Screen candidates against specific criteria, including cultural fit, and provide hiring managers with insightful and value added feedback

Who you are Successful candidates will be able to differentiate themselves through their common sense and methodical/analytical approach to solving business and talent related challenges. Individuals who enjoy working at a company where HR is perceived as a business function, adding value by providing the tools and resources to drive company success, will thrive in our culture. Professionals with a generalist background who enjoy using their diverse knowledge to contribute across all HR disciplines are encouraged to submit a resume. Strong business acumen with the ability to translate business goals into talent related initiatives is required. While recruiting will only comprise about 30% of the workload, (average req load of ~5 positions) candidates must have strong sourcing skills including utilizing LinkedIn, Meetup and job groups to identify and build relationships with passive candidates. Individuals with at least 5 years of experience and a BS degree in a related field who are interested in learning and utilizing a modern approach to Human Resources are encouraged to apply. What We Can Offer You Veracyte is a growing company which can translate into continued career opportunities for you if you are curious, driven and aspire to have a direct impact on the company’s success. Our employees regularly interact with individuals from a broad range of departments across the organization and this allows for continuous learning beyond your area of expertise. Hungry? Stop by the break room for an endless supply of peanut butter and jelly sandwiches. If you have enjoyed too many PB&J’s and need to burn a few calories, we have an on-site workout room at your disposal. To make the commute a bit more positive, we encourage the use public transportation and provide free shuttle service from both BART and Cal Train. We are a company with a heart and believe in positively impacting the world beyond our doors by providing our product to those who cannot afford it through our Afirma® Access financial assistance program. Veracyte strives to create a working environment where employees can thrive, expand their knowledge and contribute at the highest level. About the Company: Veracyte, Inc. is a commercial-stage diagnostic company pioneering the emerging field of molecular cytology. We have achieved significant success since the founding of the company four short years ago. We launched our first product, the AfirmaÃ‚Â® Thyroid FNA Analysis in the unprecedented timeframe of two and a half years. This accomplishment resulted in The Wall Street Journal selecting us as one of the top 50 venture-backed companies out of over 5,000 companies considered in 2011. In January of this year, Medicare announced their coverage decision for the centerpiece of our thyroid solution, the Afirma Gene Expression Classifier, an innovative proprietary genomic test designed to classify inconclusive thyroid nodules obtained through fine needle aspiration in the doctor office as benign or suspicious for malignancy. Studies have shown the Gene Expression Classifier has the potential to help tens of thousands of patients each year avoid surgery while reducing cost to the healthcare system. Veracyte commenced a global co-promotional partnership with Genzyme, a subsidiary of Sanofi, a world leading biotechnology company, to make the Afirma solution available to patients and physicians across the US and all over the world. Veracyte has an exciting pipeline of products aimed at addressing other significant unmet needs including our lung program addressing difficult to diagnose lung diseases and cancer. ************************************************

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See positions and apply at http://jobs.celgene.com/go/clinical-jobs/305663/?utm_source=Beaker&utm_campaign=Celgene_Tier1 Clinical jobs at Celgene IMMEDIATE Senior Clinical Scientist & CRA opportunities at Celgene, one of the most innovative biotechnology companies in the world. Celgene is a global biopharmaceutical company focused to improving the lives of patients worldwide and listed #12 on Forbes Top 100 Most Innovative Companies. Are you ready to join the team and build on Celgene's scientific and commercial achievements? ***************************************** Apply on company website Paralegal / Administrative Assistant Coherus Biosciences - Redwood City, California (San Francisco Bay Area) Job Description Position: Paralegal / Administrative Assistant Reports to: Vice President, Finance & Administration Location: Redwood Shores, California This position will support the company’s legal, business and corporate administration departments.

Work closely with the Company’s legal consultant, Chief Business Officer and VP, Finance & Administration in the preparation/organization of corporate legal documentation and contract management

Create and manage a contracts database; organize and track legal files, contracts, records, and other documentation.

Manage straightforward contract negotiations (i.e. NDAs, etc.); Research various legal issues and analyze legal documents

Work closely with others within the company during corporate transactions, negotiations, or due diligence

Assist the Chief Business Officer with completion of administrative tasks and travel as necessary.

Manage other assignments as requested Desired Skills & Experience

BA/BS or equivalent or a Paralegal Certificate; 5+ years’ experience as a Paralegal within a corporate legal team or law firm

Must have strong administrative skills and a positive, “can-do” attitude Must have basic contract drafting/negotiation experience and familiarity with basic legal

terminology, principles and documentation Must have the ability to prioritize in a fast paced environment, functioning well both

independently as well as on a team Must have an analytical mindset with attention to detail Excellent interpersonal and communication skills. Strong computer skills, particularly PowerPoint and all MS Office applications.

Company Description Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing

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the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information Posted: August 14, 2012 Type: Full-time Experience: Mid-Senior level Functions: Legal Industries: Biotechnology Job ID: 3564773 ************************************************ Please read entire job description below and if qualified, send current WORD copy of your resume to: [email protected] Associate Scientist II opportunity with Fortune 500 company in Emeryville, CA - 3517847 US based candidates ONLY, please NO sponsorship, NO relocation Our client, a global leader in the pharmaceutical industry, is looking for an Associate Scientist II to work in their Emeryville, CA, location. Responsibilities: SCIENTIFIC ASSOCIATE II - METABOLISM & PHARMACOKINETICS The MAP (Metabolism and Pharmacokinetics) department is responsible for supporting drug discovery efforts by swiftly delivering a thorough understanding of the pharmacokinetics and metabolic fate of novel chemical entities, rapidly characterizing the ADME properties of medicinal chemistry compounds, and assessing PK/PD relationships of drug discovery candidates. The department supports all aspects of metabolism and pharmacokinetics via in vitro, in silico, ex vivo and in vivo studies to ensure delivery of compounds with good drug-like properties for pre-clinical development. Seeking an individual to assist in developing LC/MS/MS assays for the quantitation of drugs and their metabolites in biological matrices. The successful candidate will also be responsible for sample analysis, data review, project tracking and report generation. In addition, this individual will conduct metabolite identification experiments using LC/MS/MS in support of the discovery of small molecule drugs. This successful candidate will also participate in MALDI imaging mass spectrometry analysis of small molecule drugs and their metabolites in rodent tissue sections. Skills: • Experience developing bioanalytical LC/MS/MS methods for the quantitation of drugs and their metabolites in support of drug discovery. • Proficiency working with 96-well laboratory automation platforms. • Experience working with other high-throughput in vitro ADME profiling assays is desirable. • A good understanding of the underlying principles of drug metabolism, pharmacokinetics and analytical chemistry is essential. • Demonstrated skills in bringing projects to completion within specified timelines.

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• Strong written and verbal communication skills are essential, along with the ability to work effectively in teams. EDUCATION: Bachelor or Masters degree in Biochemistry, Biology, Chemistry or related discipline with at least 5 yrs of laboratory experience in drug metabolism, preferably within the pharmaceutical or biotechnology industry _________________________________________________________

QC Validation Specialist opportunity with Fortune 500 Company in Emeryville, CA - 3519380

Please read entire job description below and if qualified, send current WORD copy of your resume to: [email protected] US based candidates ONLY, please NO sponsorship, NO relocation Our client, a global leader in the pharmaceutical industry, is looking for a QC Validation Specialist to work in their Emeryville, CA, location. Job Scope: Responsible for developing and validating release, in-process and cleaning methods in support of client’s immunodiagnostic products. This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods’ intended use(s) and comply with applicable regulatory and company validation requirements. Responsibilities: • Develop and validate analytical test methods for immunodiagnostic products and intermediates in accordance with ICH/USP requirements and client’s Quality Module guidelines • Write analytical method validation protocols, method validation summary reports, and method development reports • Train and provide technical assistance to fellow QC Methods Validation and QC Chemistry team members • Review method development and validation data to ensure completeness and accuracy • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH and client’s Quality Module guidelines • Develop and maintain validation project plans and their associated timelines • Perform deviation investigations and CAPA implementation in support of method validation projects • Assist technical operations staff in development and evaluation of appropriate method validation acceptance criteria • Assist Quality Control department management during inspections/audits (regulatory or internal) and audit observation responses • Assigned tasks may require standing for up to 7 hours a day, handling chemicals and potentially infectious reagents including HIV and HCV positive serum or plasma samples. May require lifting or moving materials and test equipment during the performance of assigned tasks. Education:

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Bachelors degree in Chemistry, Biology, or a related field Requirements: 10 years in a GMP environment (Pharmaceutical or Diagnostics/Device industries) with at least 5 years in analytical method validation • Highly experienced in executing analytical test method validation • Experienced in protein chemistry and immunochemistry methods such as SDS-PAGE, ELISA, reversed phase and size exclusion chromatography, absorbance assays, and Western Blots • Excellent written and communication skills, scientific report writing • Proficiency in MS Word and Excel. Proficiency in other statistical analysis software desired.

____________________________________________

Analytical Scientist opportunity with Fortune 500 company in Emeryville, CA - 3519380

PLEASE READ Due to high volume, individual profiles cannot be reviewed. Please read entire job description below and if qualified, send current WORD copy of your resume to: [email protected] US based candidates ONLY, please NO sponsorship, NO relocation ************************************************************************ Our client, a global leader in the pharmaceutical industry, is looking for an Analytical Scientist to work in their Emeryville, CA, location. Duties: Responsible for developing and validating release, in-process and cleaning methods in support of client’s immunodiagnostic products. This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods’ intended use(s) and comply with applicable regulatory and company validation requirements. • • Develop and validate analytical test methods for immunodiagnostic products and intermediates in accordance with ICH/USP requirements and client’s Quality Module guidelines • • Write analytical method validation protocols, method validation summary reports, and method development reports • • Train and provide technical assistance to fellow QC Methods Validation and QC Chemistry team members • • Review method development and validation data to ensure completeness and accuracy • • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH and client’s Quality Module guidelines • • Develop and maintain validation project plans and their associated timelines • • Perform deviation investigations and CAPA implementation in support of method validation projects • • Assist technical operations staff in development and evaluation of appropriate method validation acceptance criteria • • Assist Quality Control department management during inspections/audits (regulatory or

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internal) and audit observation responses • • Assigned tasks may require standing for up to 7 hours a day, handling chemicals and potentially infectious reagents including HIV and HCV positive serum or plasma samples. May require lifting or moving materials and test equipment during the performance of assigned tasks. • Timely execution of approved method validation protocols according to established plan. o Timely completion of written method validation protocols and reports. SKILLS: 10 years in a GMP environment (Pharmaceutical or Diagnostics/Device industries) with at least 5 years in analytical method validation • • Highly experienced in executing analytical test method validation • • Experienced in protein chemistry and immunochemistry methods such as SDS-PAGE, ELISA, reversed phase and size exclusion chromatography, absorbance assays, and Western Blots • • Excellent written and communication skills, scientific report writing • Proficiency in MS Word and Excel. • Proficiency in other statistical analysis software desired. EDUCATION: Bachelor degree in Chemistry, Biology, or a related field

******************************************************** If you meet the above requirements, please forward a copy of your resume (word format) to [email protected] for confidential review Chemist, Santa Clara, CA Job Description: Our client is seeking a Chemist to work out of their Santa Clara, CA location for approximately 6 months (extension possible.) This individual will support Reagent development and assist in the development of novel reagents and in their manufacturing processes. He/she will be responsible for Design of experiments and testing schemes, data analysis, writing protocols, and performing and/or developing various procedures used to prepare chemical buffer solutions. Requirements Must possess a degree (MS or PhD preferred) in chemistry, molecular biology or biochemistry with 3-5 years (minimum) relevant experience. Knowledge of GMP, ISO, and FDA regulations and audits a plus. Familiarity with process and test method validations. Strong documentation skills, strong GMP, GLP. US based candidates ONLY, please - NO sponsorship, NO relocation ********************************************************************* For consideration, please email resumes to [email protected] and include “Sales Representative” in the subject line. Please include your salary history and requirements.

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For more information on HOYA Corporation USA, please visit our website at www.hoyaoptics.com.

Sales Representative Hoya, established in 1941 as Japan's first specialty manufacturer of optical glass, has diversified into new business areas that exploit the potential of advanced optics technologies. The company has continued to grow as a global enterprise through the expansion of its diverse business activities, which encompass electro-optics, photonics, vision care, healthcare and crystal products. HOYA Corporation USA, located in Santa Clara, CA, is looking for a dedicated, talented, contributor to share in our fast growing environment as a Sales Representative. Essential Duties and Responsibilities:

Primarily focus on increasing sales of colored filter glass, optical glass and specialty glass materials

Maintaining and growing current customer accounts Develop new sales by cold calling or through sales leads from trade shows Maintain a clear record of the progress of all customer contact Prepare and present quotations Achieve and exceed assigned sales goals Must be able to establish and maintain strong relationships throughout the sales cycle Flexibility and ability to work in a team environment, you must be a team player

Requirements:

Bachelor’s degree or 2 to 3 years sales related experience Excellent verbal and written communication is necessary, second language is a plus Negotiating and organization skills Ability to calculate figures and amounts such as discounts, interest, proportions,

percentages, area, circumference and volume. Ability to apply concepts of basic algebra and geometry.

The ability to work collaboratively with internal and external resources to generate results

Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract concrete variables.

Strong computer skills (Excel, Word, PowerPoint, Outlook) HOYA Corporation USA is committed to providing its employees with the best program of benefits possible. Hoya Corporation USA is an Affirmative Action / Equal Employment Opportunity employer. ******************************************************** Posted by Katie Lepper, ACIR, CIR, CDR, CSSR, Recruiter at The RightThing, An ADP Company Now Hiring! Amgen sales expansion in the Bone Health Group. Seeking entry level pharma reps! (Sacramento, CA) Title Biopharmaceutical Rep, Bone Health - Sacramento N, CA Career Category Sales Employee Subgroup Sales Incentive FT Country (State/Region) United States - California Amgen Job Description Territory #88253 Sacramento N, CA... Job Description Title Biopharmaceutical Rep, Bone Health - Sacramento N, CA Career Category Sales Employee Subgroup Sales Incentive FT

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Country (State/Region) United States - California Amgen Job Description Territory #88253 Sacramento N, CA Amgen has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. As a Biopharmaceutical Sales Representative, you will act as the primary customer contact and educate prescribers about Amgen products consistent with current compliance guidelines. In this entry-level sales role, you will provide comprehensive clinical and access-related information tailored to target prescribers. As a Biopharmaceutical Sales Representative, you are expected to achieve and or exceed territory sales targets by developing and executing Plan of Action (POA) marketing strategies, which include delivering branded sales messages and executing planned programs and by developing and executing territory plans in consultation with your District Manager. Biopharmaceutical Representatives are also responsible for ensuring product access and, resolving/triaging reimbursement issues within the retail fulfillment pathway Basic Qualifications Bachelor’s Degree OR Associate’s Degree with 4 Years directly related experience OR High School Diploma/GED with 6 Years of directly related experience AND A valid driver’s license to operate an Automobile Preferred Qualifications Because this position does not require previous sales experience, the preferred candidate will exhibit: Adaptability Business Acumen Knowledge of Healthcare Industry Persuasiveness/Sales ability Work Ethic/Initiative Practical Learning Ability Problem Solving Planning and Organization skills Alignment with the Amgen values ************************************************* David Kohl, Sr. Recruiter at Onyx Pharmaceuticals Hiring - Drug Safety Professionals - ONYX hire.jobvite.com The Drug Safety Associate I encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Responsible for all aspects of adverse event processing and reporting for assigned investigational and marketed products, while maintaining compliance with Onyx SOPs and FDA, ICH and worldwide regulations to ensure

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uniform and timely processing and reporting of adverse event reports. Serves as a liaison to external healthcare providers, investigational site *********************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2011 on the biotechnology industry at www.ey.com. This is the 25th anniversary issue using consistent measures to track the industry sector. *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2012 report authored by CHI, PWC and BayBio at http://baybio.org/about/2012-biomedical-report/ ******************************************************* NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 **************************************************** Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace”’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • “[email protected] ” ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.”

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The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at [email protected]. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background

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Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job.

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8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at [email protected], phone her office (650-286-9300), see her

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LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. *************************************************************************Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://the-scientist.com/2011/12/01/life-sciences-salary-survey-2011/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/issues/2011-06/view_features/2011-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/salary-survey-2010-research-and-development. You can also find salaries for other functions at the same location. 2011 is now available at http://www.mddionline.com/article/salary-survey-2010-research-and-development MM&M reports salaries in the September issue each year. See 2011 results at http://www.mmm-online.com/25th-annual-career-salary-survey/article/211850/ ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development

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manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at [email protected] if they wish to receive these mailings directly. *************************************************************************

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