Job Description: «Attach and Train» Biologics Trainee Job ... · Job Title: Biotechnologist,...

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Job Description: «Attach and Train» Biologics Trainee Job Title: Biotechnologist, Mammalian Manufacturing Department: Mammalian Manufacturing

This document is intended solely for the use of Lonza Singapore employees and is not to be disseminated outside the Lonza Group. It may contain information that is confidential and / or

proprietary to Lonza Singapore or its customers. Inappropriate use of this information may result in disciplinary action.

Responsibilities The Biotechnologist is responsibe for the manufacutre of therapeutic proteins under cGMP conditions. Expectations for each position are built upon those described in the preceding level. This position reports to the Senior/ Section Lead/ Manager of the Large of Small Scale Manufacturing Team. Equipment Expertise (All sections)

Learn & perform well defined procedures

Pursue ongoing training to increase knowledge & understanding

Attain basic understanding of cGMP requirements & compliance within a GMP manufacturing setting

Perform assigned tasks (by Section Lead/ Manager) both with and without supervision

Perform equipment monitoring & and basic 6S housekeeping

Perform basic laboratory tasks (eg: sampling, pH/ conductivity/ osmolality measurements etc.)

Perform routine sanitization tasks to maintain facility standards

Achieve & consistently maintain a training status of ≥ 90%

100% trained & signed off on Performnace Measures (PMs) relating to CIP/ SIP/ basic tank & instrument operations

Demonstrate aseptic technique in the handling of product materials

Perform tasks independently in ≥ 80% of manufacturing areas assigned eg. USP/ DSP/ PST

Perform basic process & equipment troubleshooting

Able to multi-task on equipment preparations & operations to ensure adherence schedule

Attain full competency in the performance of all operations relevant to manufacturing areas assigned

100% trained in all related manufacturing operations

Display basic process & equipment troubleshooting ability under routine scenarios. Technical Process Expertise (All sections)

Exhibit basic understanding of critical process/ operational parameters and target/ acceptable ranges

Exhibit basic understanding of the entire process eg. interactions between different process parameters.

Understand process flow from scheduling & resource loading perspective.

Display basic awareness of operational factors, which influence the process

Work effectively interdepartmentally, providing manufacturing insights & support to MSAT, Lot Review and Deviation Investigation groups.

Systems & cGMP Expertise (All Sections)

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Use Standard Operating Procedures (SOPs), logbooks & Batch Records (BRs) effectively & competently.

Understand in general the Lot Review process/ workflow

LIMS (Laboratory Information Management System) trained & competent in the submission of samples via LIMS

Attain operating knowledge of PWCS (Plant Wide Control System)

Understand the deviation system/ workflow overview

Understand the Kanban system overview & competent in ordering of consumables, BRs traceable & logbooks

Perform logbook & 1st level BR review effectively & competently

Operate PWCS independently for daily routines.

Understand emergency materials requisition process/ workflow.

Execute validation activities as per instructed. Specific Skillset Buffer/ Media preparations

Understand there are different setup and equipment use between customers for different operations. Eg. CIPs and buffer/ media transfer.

Able to identify and install the different set up and equipment for different customers for different operations. Eg. CIPs and buffer/ media transfer.

Understand the criticality of setting up the right path and equipment for different customers.

Understand the different set up and the equipment use between single use and the conventional stainless steel equipment.

Dispensing/ Sampling/ Autoclave/ Equipment Wash

Able to identify the correct materials by part number and FEFO lots.

Select appropriate Dispensing Booth’s Hoods and Weight balance.

Identify sampling requirements based on material RMS.

Assemble Autoclave assembly per SOP.

Able to perform equipment wash without stain and residues. Cell Culture (Upstream small/ large scale)

Basic skill and knowledge f aseptic technique for subculture stages example using culture flask, spinners, wave bioreactors, etc.

Basic technical knowledge on the bioreactor culture control example pH/ DO control, CO2/ O2 control, cell performance and metabolites analysis.

Purification (Downstream small/ large scale)

Basic skill and knowledge of column chromatograpy techniques, tangential flow, filtration techniques, micro/ Nano filtration techniques. pH/ Conductivity adjustment techniques, aseptic techniques.

Basic technical knowledge on the chromatography operating interface example using UNICORN software and various DeltaV control parameters for chromatography and UF operation.

Basic knowledge in single use applications for the respective processes. Problem Analysis/ Decision Making (All sections)

Make basic decisions eg. know when to seek help & who to contact

Identify situations which may require further escalation to Section Lead/ Manager.

Provide appropriate immediate actions in situations, which will require further escalation.

Recognize abnormal and/ or potential events, which affect operations, product quality and/ or safety & escalate to the appropriate level of attention.

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Planning/ Comunication (All sections)

Organize & plan assigned daily activities to ensure timely completion of all assignments

Document all work as it occurs

Ensure all BRs related materials eg. dispensing, consumables, traceable, cleaned/ autoclaved parts etc. are available in advance of scheduled usage.

Ensure all equipment are ready for production use (ie. within CIP/ SIP expires) in advance of scheduled usage.

Communicate to a level where appropriate questions are asked to increase understanding of role.

Present facts in a logical, concise & accurate manner while checking for understanding.

Offer suggestions/ options to Section Lead/ Manager on process/ scheduling issues.

Draft shift notes.

Support Operational Excellence (OE) visual management tools & systems.

Write & perform shift exchange in the absence of Section Lead/ Manager.

Support multiple and/ or changing priorities of floor activities.

Support upcoming suite activities & actively coordinate with other departments.

Offer and implement improvement suggestions relating to process/ scheduling/ costs/ operational workflows.

Supervision Received (All sections)

Report to Section Lead/ Manager

Receive daily supervision on routine work & detailed instructions on new assignments.

Able to work indelendently to perform manufacturing activities.

Receive minimal supervision and ensure job assignments are progressing per schedule.

Any other duties as assigned by your Supervisor Manager. Education Experience

Degree/ Diploma/ NITEC in a related Science/ Engineering discipline

Fresh graduates are welcome

Individual without prior working experience in the biopharmaceutical manufacturing industry may also apply

Knowledge of cGMP applications

Positive team oriented attitude

Strong communication and interpersonal skills

Willing to perform rotating 12-hour shift pattern Competencies

Business Acumen

Customer Focus

Driving Results

Leadership

Collaboration

Agility

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Job Description: «Attach and Train» AnT Biologics Trainee Job Title: AnT Trainee – Process Development, Maufacturing Sicence and Technology, Mammalian Department: Manufacturing Science and Technology, Mammalian



Responsibilities Technology Transfer:

Support the timely and successful transfer of the customer’s manufacturing process into the Lonza Singapore production facility. Work with other team members to support technology transfer.

Perform/ support experiments in the MSAT scale-down process lab to support process technology transfer. Follow all applicable lab safety policies.

Provide floor and on-call support for projects being transferred.

Work closely with customers to identify and resolve tech transfer gaps and process issues.

Write master batch records and develop operator training packages.

Deliver pre-campaign training and perform post-campaign reviews of assigned processes.

Support investigations into process issues or deviations, write minor/ major deviations are assigned.

Process Support:

Support/ lead pre-campaign preparation activities (BR review, training, change requests) for assigned projects per pre-defined schedule.

Provide floor and on-call support during production. Escalates issues to management approprately and interface with customer on issue resolution.

Compile and disseminated daily process updates.

Ensure presence on the floor to support production and MSAT review of operations.

Support investigations into process issues or deviations, write minor/ major deviations. o Support/ lead the investigation into process trends to support process monitoring

requirements, support prepartion of APR and CPV reports, perform work-stages to support customer BLA filing.

Keep current appropriate databases with MFG process data and analyze to monitor run to run consistency for manufacturing operations and identify opportunities for improvement.

Support inspections and audits by customer and regulatory authorities as required.

Any other duties as assigned by your Supervisor/ Manager. Education Experience

Degree in a related Science or Engineering discipline such as Biotechnology, Biological Science, Chemistry, Biomedical Engineering, Chemical Engnineering


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Requirements


Good problem solving and analytical skills

Good communication skill

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Job Description: «Attach and Train» AnT Biologics Trainee Job Title: AnT Trainee – Process Development, Maufacturing Sicence and Technology, Cell & Gene Technology Department: Manufacturing Science and Technology, Cell & Gene Technology



Responsibilities Technology Transfer:

Support the timely and successful transfer of the customer’s manufacturing process into the Lonza Singapore production facility. Work with other team members to support technology transfer.

Perform/ support experiments in the MSAT scale-down process lab to support process technology transfer. Follow all applicable lab safety policies.

Provide floor and on-call support for projects being transferred.

Work closely with customers to identify and resolve tech transfer gaps and process issues.

Write master batch records and develop operator training packages.

Deliver pre-campaign training and perform post-campaign reviews of assigned processes.

Support investigations into process issues or deviations, write minor/ major deviations are assigned.

Process Support:

Support/ lead pre-campaign preparation activities (BR review, training, change requests) for assigned projects per pre-defined schedule.

Provide floor and on-call support during production. Escalates issues to management approprately and interface with customer on issue resolution.

Compile and disseminated daily process updates.

Ensure presence on the floor to support production and MSAT review of operations.

Support investigations into process issues or deviations, write minor/ major deviations. o Support/ lead the investigation into process trends to support process monitoring

requirements, support prepartion of APR and CPV reports, perform work-stages to support customer BLA filing.

Keep current appropriate databases with MFG process data and analyze to monitor run to run consistency for manufacturing operations and identify opportunities for improvement.

Support inspections and audits by customer and regulatory authorities as required.

Any other duties as assigned by your Supervisor/ Manager. Education Experience

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Degree in a related Science or Engineering discipline such as Biotechnology, Biological Science, Chemistry, Biomedical Engineering, Chemical Engnineering



Requirements




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Job Description: «Attach and Train» Biologics Trainee Job Title: AnT Trainee – Analyst, Quality Controls, Mammalian Department: Quality Controls, Mammalian



Responsibilities

Analysis of environmental, raw materials, in-process and final bulk product samples according to Standard Operating Procedures and Test Methods

Documentation of results in accordance with current Good Manufacturing Practices (cGMP)

General lab support including housekeeping, equipment maintenance, inventory of supplies, etc.

Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next

Perform routine testing with supervisor direction

Perform general lab support

Complete GMP and Safety Training

Specific Areas of Responsibility:

Microbiology/EM Area: Understanding of basic and intermediate microbiology techniques (bioburden, LAL, plating and counting techniques, EM tests i.e. water/steam/gas sampling, air sampling, surface viable sampling, total particulate sampling etc.). Collecting environmental monitoring samples from different areas of the facilities, generation of required trending and reporting information. Assist in process and/ or environmental microbiology related investigations as required.

Analytical/Biochem Area: Basic understanding and execution of spectroscopy, assigned basic methods which may include chromatography methods, Elisa, PCR, osmolality, potency methods, appearance and other physiochemical methods.

Raw Materials Area: Basic understanding and execution of compendial monographs, chemistry fundamentals behind less complex methods.

Education

Degree in a related Science or Engineering discipline such as Biotechnology, Biological Science, Chemistry, Biomedical Engineering, Chemical Engineering



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Requirements




Willing to perform shift duty when required

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Job Description: «Attach and Train» Biologics Trainee Job Title: AnT Trainee – Analyst, Quality Controls, Cell & Gene Technology Department: Quality Controls, Cell & Gene Technology



Responsibilities

Analysis of environmental, raw materials, in-process and final bulk product samples according to Standard Operating Procedures and Test Methods

Documentation of results in accordance with current Good Manufacturing Practices (cGMP)


Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next

Perform routine testing with supervisor direction

Perform general lab support

Complete GMP and Safety Training

Specific Areas of Responsibility:

Microbiology/EM Area: Understanding of basic and intermediate microbiology techniques (bioburden, LAL, plating and counting techniques, EM tests i.e. water/steam/gas sampling, air sampling, surface viable sampling, total particulate sampling etc.). Collecting environmental monitoring samples from different areas of the facilities, generation of required trending and reporting information. Assist in process and/ or environmental microbiology related investigations as required.

Analytical/Biochem Area: Basic understanding and execution of spectroscopy, assigned basic methods which may include chromatography methods, Elisa, PCR, osmolality, potency methods, appearance and other physiochemical methods.

Raw Materials Area: Basic understanding and execution of compendial monographs, chemistry fundamentals behind less complex methods.

Education




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Requirements




Willing to perform shift duty when required

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Job Description: «Attach and Train» AnT Biologics Trainee Job Title: AnT Trainee – Quality Assurance, Cell & Gene Technology Department: Quality Assurance, Cell & Gene Technology



Responsibilities

Support day-to-day Quality Assurance activities in accordance with approved SOPs/ Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.

Take on role of QA Specialist in one of 4 areas: Quality Systems, QA Engineering, QA SCM/QC or Quality Operations.

Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knolwedge or field experience

Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.

Participate in walk down and begin to provide usable feedback.

Generally provide basic compliance support to staff in all departments

Demostrate appropraite interpersonal skills that encourage collaboration of individuals or teams to meet objectives

Any other tasks as and when assigned by supervisor

Education Experience




Requirements


Good communication skills


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Job Description: «Attach and Train» Biologics Trainee Job Title: AnT Trainee – Biotechnologist, Cell & Gene Technology Department: Cell & Gene Therapy



Responsibilities Cell Therapy Biotechnologists are expected to execute cGMP Cell Therapy production activities through to filling of final dose product within a stringent cGMP clean room environment. As a member of the Cell Therapy Manufacturing team the aim of this position is to develop expert technical knowledge and flawless execution of the Cell Therapy production process. Production activities occur in the classified production suite which requires change into clean room clothing and compliance with clean room standards.This includes removal of jewelry/makeup, donning of over suits/coveralls, safety shoes, shoe covers/booties, hair cover, gloves and safety glasses/shield. Some private office work and conference room meetings will be required. This position could be an ideal opportunity for someone with an interest in Cell Therapy production wanting to develop their production career in a different technical/scientific area. Thorough training and continual assessment will be provided. After training successful applicants would be expected to join day, weekend and public holiday rotas / shift. Note: responsibilities increase in line with step level. a) Primary Responsibilities

Complies with site/department EHS standards (policies, rules and regulations).

Attains a thorough understanding of the principles of cGMP compliance and clean room practices.

Contributes to appropriate maintenance of ‘in-operation’ production facilities and equipment e.g. cleaning & sanitisation, equipment monitoring, sampling, pH and conductivity checks.

Solution and medium preparation followed by aseptic filtration into sterile containers.

Revival and culturing of anchorage dependent cell lines in static flasks and cell factories

Harvest and concentration of cell factory generated cell cultures using tangential flow filtration or/and centrifugation.

Final formulation and filling of vials.

Visual inspection and cryopreservation.

Participation in aseptic process simulations.

Accurate and thorough completion of batch record documentation.

Environmental monitoring (viable particulates, non-viable particulates, surface and operator).

Formulation of media and aseptic filling of media bags and bottles.


Bachelor’s Degree in Life Sciences or related discipline and cGMP experience in the biotech/pharma manufacturing sector.

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Knowledge of cell culture and the principles of aseptic processing within a classified environment.

Strong team oriented work ethic. Competencies

Attention to detail

Planning, Organising, & Controlling

Effective Communication - clear and concise (both written and oral).

Professional

Team player

Flexible All Lonza Biologics Employees have the following responsibilities:

cGMPs is required at all times during the manufacture of therapeutic products.

All personnel are responsible for notifying responsible Management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).

All personnel should practice good sanitation and health habits.

Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of therapeutic products.

All personnel are required to provide support in maintaining the site safety, health and environmental programs and system.

Adherence to SHE rules and regulations is required at all times.

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Job Description: «Attach and Train» AnT Biologics Trainee Job Title: AnT Trainee – Scientist, Development Services, Mammalian Department: Development Services, Mammalian



Responsibilities

Development Services encompasses three technical disciplines with associated support functions to develop processes to enable manufacture of recombinant protein therapeutics. A role will be available in one or more of the technical functions dependent on the business needs of the department and the candidate’s experience.

Cell Culture Development: Responsible for the development of cell lines and cell culture processes.

Purification Development: Responsible for the development of purification processes and supply of protein samples for analytical development.

Analytical Services: Responsible for analytical testing for both the cell culture and purification teams alongside analytical studies supporting regulatory filings.

Duties and Responsibilities include but are not limited to:

Adherence to EHS rules and regulations is required at all times.

Under guidance of supervisor/science lead perform the following activities dependent on the team in which the trainee is placed: Routine cell culture (cell line development and bioreactors), analytical methods aligned with individuals training, routine downstream process development (material supply/process evaluation).

Document results in accordance with Lonza policies and current Good Manufacturing Practices (cGMP)


Troubleshooting equipment issues and an interest in operational efficiency


Degree in a relevant Science field or equivalent



Understanding of the application of mammalian cell culture for the production of biopharmaceuticals

Understanding of cGMP regulations

Good problem solving and anlytical skills

Good communication and teamwork skills

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Competencies Decision Making

Planning/Organizing

Effective Communication

Personal Orientation

Teamwork

Customer focus

All Lonza Biologics Employees have the following responsibilities:

Quality should be the responsibility of all Lonza employees. Adherence to cGMPs is required at all times during the manufacture of APIs.

All personnel are responsible for notifying responsible Management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.)

All personnel should practice good sanitation and health habits.

Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.

All personnel are required to provide support in maintaining the site safety, health and environmental programs and system.

Adherence to EHS rules and regulations is required at all times.

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Job Description: «Attach and Train» AnT Biologics Trainee Job Title: AnT Trainee – Process Engineer, Engineering Services Department: Engineering Services



Responsibilities

The Engineer provides operational improvement and process support for the successful and uninterrupted operation of biologics manufacturing systems such as bioreactors, purification equipment, media & buffer systems, heat/cooling systems and CIP/SIP equipment.

Develop and implement best practices and play a key role in improving manufacturing success rates and cost efficiency, maintaining compliance according to cGMP standards and providing for a safe work environment.

As process technical resource, provide daily operational support and project execution including, modifications and changes to processes and equipment, process troubleshooting, root cause analysis and deviation investigation.

Participate and lead, when required, in all investigations (contaminations, deviations, and discrepancies) relating to the manufacturing process and propose CAPA.

Involve in new customer tech transfer process fit out and risk assessment. Support customer queries and provide necessary support to address process related issues.

Propose and evaluate modifications to equipment, processes and operations to improve safety, efficiency and cost to meet site specific performance indicators.

Supervise external contractors to develop and implement Capital projects and plant modification.

Basic knowledge of upstream and downstream processing unit operations.

Support the team on inspection readiness at all time.

Any other duties as assigned by your Supervisor/Manager Education Experience

Diploma or Degree in Engineering disciplines



Good understanding in process equipment design and operation

Strong problem solving ability, troubleshooting and analytical skills

Strong written and oral communication skills

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Competencies

Excellent Communication Skills

Able to communicate effectively with co-workers / team members to align and clarify job assignments

Project Management Skills

Demonstrates ability to organize & plan for daily activities to ensure timely completion of assignments

Teamwork/Collaboration

Able to collaborate with peers & staff across various departments / functions to effectively complete job assignment

Follow-up and Initiative

Problem Solving

Able to identify simple problems quickly and develop solutions to resolve them in an effective manner

Demonstrates basic ability to analyze and interpret data and is able to develop solutions with guidance

Good Manufacturing Practices

Understands basic GMP, GDP & GEP principles and requirements

Job Description: «Attach and Train» Biologics Trainee Job ... · Job Title: Biotechnologist,...

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