Patrick FlanaganPatflan101@gmail.com 3 Beacon Street, Uxbridge, MA 01569 (508) 612-6527PROFILEExperience in project management on CMC and AST teams, cGLP/cGMP operations, and quality systems. Strong interdisciplinary communication skills and public speaking abilities. Extensive industry experience in clinical fill finish, liquid and solid dosage forms of formulation development, protein solution behavior, biophysical characterization, and analytical chemistry.

Led cross-functional teams focused on Develop-ability assessments of potential drug candidates. This included guiding projects involving numerous groups and employees all directed toward as single goal. I developed study plans and schedules, assessed risk to programs, and checked on the progress of all assignments.

Coordinated and strategic planned resources and facilities for laboratory purchases and moves. Integral in procurement of capital lab equipment steered to accomplish long-term group objectives. Such moves included completely updating all lyophilization research capabilities within research and development.

Coordinated numerous meetings for various Formulation and Develop-ability projects, which included agenda setting, meeting logistics and coordination of venues.

Served as BFD representative at CMC and AST meetings for numerous concurrent programs.

Served as BFD invited speaker at external scientific conferences, internal discovery and development meeetings. Representing both programs and entire work flow philosophies. I have served as the primary spokesperson for numerous formulation programs.

Led and coordinated numerous meetings for various Formulation and Develop-ability projects which included agenda setting, meeting logistics and coordination of venues.

WORK EXPERIENCEGenzyme, a Sanofi Company Framingham, MA Principal Research Associate 2014 – present

Supervised multiple employees Hands on experience in cGMP fill/finish operations for Phase 1/Phase 2 drug products Formulation representative at CMC and analytical sub teams for multiple concurrent programs Formulation project lead for multiple concurrent programs Developed tangential flow filtration processes for numerous proteins Characterized and developed formulations for monoclonal antibodies, glycoproteins, fusion proteins,

antibody-drug conjugates Experienced in method development/optimization for new products and methods to minimize

material consumption Expertise in “manufacturability” and “developability” of potential therapeutics during the discovery

phase of development Expertise in aggregation analysis, including SEC-HPLC and multi-angle light scattering Proficient in analytics monitoring chemical and physical stability Responsible for communicating program results in small and large public speaking forums Responsible for authoring technical reports and regulatory memos Investigated, purchased , and implemented a wide range of new technologies pertinent to

formulation development Responsible for laboratory training of new employees, safety, and purchasing

Senior Research Associate 2010 – 2014 Research Associate 2005 – 2010

Genzyme Framingham, MA Quality Control Analyst II 2003 – 2005

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P.Flanagan (508) 612-65273 Beacon Street, Uxbridge, MA 01569 patflan101@gmail.com

Performed in-process, release and stability assays on Sepra and sodium hyaluronate (HA) products using current S.O.P.’s in a cGMP laboratory.

Responsible for verifying chemical accuracy of S.O.P.’s and revising accordingly Familiar with compendial testing Coordinated metrology and documentation programs, including creating a handbook for the

metrology liason Trained new analysts in all lab procedures Often responsible for problem solving assays Proficient in wet chemistry, viscometry, rheometry, nephelometry, gas chromatography,

spectrophotometry, FTIR, pH, and conductivity Quality Control Analyst I 2002 – 2003

EDUCATIONUMass Amherst Isenberg School of Management Amherst, MA

Fall 2016 - CurrentWorcester Polytechnic Institute, Bachelor of Science/Biochemistry Worcester, MA Bachelor of Science, Biochemistry 2002

Major Qualifying Project Title: Expression of CPx-ATPases in Arabidopsis thaliana Principal Advisers: Dr. Jose Arguello Project Summary: Researched the transcriptional expression of genes for heavy metal ATPases

RAN1 and HMA4 in Arabidopsis thaliana.. Research Skills RNA extraction, DNA maxi and mini preparations, Northern and Western blotting, Recombinant DNA

procedures, Sterile technique, SDS-Page, and enzyme kinetics testing. Specialized Training “Lyophilization Principles and Practices” 2015

SP Scientific “Circular Dichroism Application Training” 2010

Jasco Analytical Instruments “Lyophilizaton Technology for the Pharmaceutical and Biotechnology Industries” 2009

Biopharma Technology Ltd “Light Scattering University” 2007

Wyatt Technologies Relational OS – Mediation Training 2007

Integral Center

PUBLICATIONS, PATENTS and POSTER PRESENTATIONSFlanagan, P.; Simler, R.; Guziewicz, N., Perez-Ramirez, B., Preformulation characterization of Anti-VEGF receptor for microencapsulation. Poster for Genzyme Science Offsite. September 2009.Sun, S.; Flanagan, P.; Woinet, B.; Simler, R.; Perez-Ramirez, B., Flexibility in protein dosage form development through priling technology: An application to product life cycle management. Poster for Genzyme Science Offsite. September 2013. INVITED TALKS“Methods and approaches for early stability assessment of potential biotherapeutics to support manufacturability” The Bioprocessing Summit (Boston, MA) August, 2013.

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