Training And Development In Pharmaceutical Company

Terry O. Moore

74 Myrick Lane  ∙  Harvard, MA  ∙  01451 978­772­4850  ∙  [email protected]

Professional Experience Histogenics Corporation  Waltham, MA  2008  A tissue regeneration company developing breakthrough treatments for long­lasting joint repair.  Two cartilage regeneration products (one combination product and one medical device) apply  advanced   cell   biology,  tissue   engineering,  and   materials   science   in   the   repair  of   injured  or  diseased joints, to restore function and prevent degenerative disease.   2008 Director, Quality  Direct the company’s quality assurance and quality control activities to ensure compliance with  CGMPs Part 211, Part 820, and ISO requirements. Supervise a staff of four, including a QA  Manager, QC Manager,  and two contract quality associates.  • Responsibilities include supervising QA/QC activities and associated staff.  Responsible for  improving   quality   systems   in   accordance   with   CGMPs   and   QSR   to   prepare   for   Phase   3  manufacturing.   •

Evaluate   departmental   resource   needs   and   develop   budget   recommendations;   oversee  training and development of staff; review and approve all departmental reports.

Johnson Matthey Pharma Services  Devens, MA  2006 ­ 2008 A   pharmaceutical   contract   manufacturer   and   chemistry   services   company   providing   Active  Pharmaceutical   Ingredients   (API)   outsourcing   solutions   throughout   the   drug   development  process, from early stage discovery services to commercial manufacturing. 2006 – present Manager, Quality Assurance Direct JMPS QA activities to ensure compliance with Q7A requirements. Supervise a staff of  seven, including five QA Associates and two Documentation Specialists.  • Responsibilities include supervising QA activities, associated staff, interacting with clients,  and training internal groups.  Responsible for improving quality systems in accordance with  ICH Q7A and CGMPs to prepare for commercial manufacturing.   • Conducting  and  overseeing   auditing   activities,   including   raw material  vendor  evaluations,  contract test facilities, service providers • Active participant in validation activities: test methods, equipment, software, and process •

Participate and coordinate FDA inspections and inspections by other regulatory agencies,  including Pre­Approval inspections 

•

Approve and release final APIs

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•

Evaluate   departmental   resource   needs   and   develop   budget   recommendations;   oversee  training and development of staff; review and approve all departmental reports.

Consultant    Harvard, MA  2005 ­ 2006 Provide  quality assurance and quality control consulting for the biopharmaceutical industry,  including   document   review,   document   preparation   for   FDA   submissions,   planning,   project  management, reporting, and other related services.

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Therion Biologics Corporation  Cambridge, MA  1992 – 2005 A   privately­held   biotechnology   company   engaged   in   the   development   of   therapeutic   viral  vaccines for cancer and AIDS. 2003 – 2005 Director, Quality Assurance Direct Therion’s QA activities to ensure compliance with CGMPs, GLPs, and GCPs. Supervise  a staff of eight, including a QA Manager, Validation Manager, four QA Specialists, and two  Documentation Specialists.  • Responsible for improving quality systems in accordance with all government regulations and  consistent   with   CGMPs   to   prepare   for   Phase   3/launch   manufacturing.     Includes   CAPA,  investigations, deviation reporting, change control, vendor qualification, and audit program.  Member of the selection team for a Quality Management System.   Reviewed and approved  validation master plan and qualification documents for the validation of TrackWise®. • Directed   validation   efforts   for   a   newly   constructed   Class   10,000   manufacturing   facility  (facility/HVAC/BCS, autoclave, WFI, RODI, isolator/filler, VHP, depyrogenation oven, vial  washer,   process   and   QC   equipment).     Key   participant   in   the   selection   of   process   and  manufacturing equipment and in the overall design of the manufacturing facility.  • Assisted in the development and supervised the Part 11 compliance plan.   Reviewed and  approved the validation master plan, qualification documents, and required SOPs for network  qualification and QC equipment. • Assisted   in   the   preparation   of   CMC   sections   of   regulatory   submissions.     Received   2004  outstanding achievement award as member of the CMC team. • Active member of the Supply Chain Management team • Active  member  of  the  Packaging  and  Labeling  team  to develop  materials  for launch  and  commercial manufacturing • Initiated preparation for Pre­License Inspection • Implemented personnel and job­specific training program • Directed   all   internal   and   external   audits   (GMP,   GLP,   GCP,   vendor   qualification   for   raw  materials, test facilities, and CROs) • Developed and directed execution of cleaning validation project.  Drafted cleaning validation  master plan. • Extensive involvement in technology transfer of new manufacturing process.  Assisted in the  development of production batch records and provided input on testing requirements. • Approved and released product for clinical trials • Strategic, operational, and human capability planning for the QA department and personnel.  Evaluated departmental resource needs and developed budgets.

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2000 – 2003 Director, Quality Assurance/Quality Control Direct   Therion’s   QA/QC   activities   to   ensure   compliance   with   CGMPs,   GLPs,   and   GCPs.  Supervise a staff of thirteen, including a QC Manager, a QA Supervisor, seven QC Analysts,  three QA Specialists, and a Documentation Specialist. • Responsible   for   developing   and   implementing   quality   systems   in   accordance   with   all  government regulations and consistent with CGMPs to prepare for Phase 3 manufacturing • Directed validation efforts for a newly renovated facility (autoclaves, WFI, purified water,  batchwasher, facility/HVAC, cleaning, misc. manufacturing and QC equipment). Hired and  supervised validation consultants as their primary liaison. Developed Validation Master Plan. • Oversaw   all   contract   testing   (review   and   approval   of   study   protocols   and   final   reports,  scheduling, etc.). Evaluated and selected new contract  test facility to perform 70% of all  product testing. • Participated   in   the   preparation   of   manufacturing,   control,   and   other   technical   sections   of  regulatory submissions (Pre­IND documents and two INDs) • Project Management training: Project Leader for GxP compliance plan dealing with facility  and equipment, personnel, materials, methods, and quality systems • Retained   all   responsibilities   from   previous   Associate   Director,   QA/QC   position:   approve  product   for   clinical   trials;   evaluate   departmental   resource   needs   and   develop   budget  recommendations;   oversee   training   and   development   of   staff;   review   and   approve   all  departmental reports; direct all internal and external audits. 1997 – 2000 Associate Director, Quality Assurance/Quality Control Responsible for ensuring compliance with CGMP and GLP regulations. Directed a staff of six,  which included one QC Manager, four QC Analysts, and one QA Specialist. • Directed  all  Quality  Assurance  systems,  including   the  establishment  of  a  formal  auditing  program. Directed all internal and external audits. • Oversaw   all   contract   testing   (review   and   approval   of   study   protocols   and   final   reports,  scheduling, etc.) • Prepared   and   coordinated   the   compilation   of   manufacturing,   control,   and   other   technical  sections for FDA submission (20 Type II Master Files and associated amendments) • Approved product for use in clinical trials • Reviewed   and   approved   all   departmental   reports,   including   deviations,   problem  investigations, validation reports, and change control reports. • Directed all training and development of the staff. Determined goals for the staff that were  consistent with company objectives and goals. • Evaluated resource needs for the department and prepared budget recommendations for staff  and equipment

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• Directed the technical transfer of assays from Assay and Process Development to Quality  Control • Coordinated technology transfer from Process Development to Manufacturing to ensure that  changes were consistent with QC sampling and testing methods 1992 – 1997 Manager, Quality Assurance/Quality Control Responsible for ensuring compliance with CGMP and GLP regulations. Managed a staff of one  supervisor and three to four QC technicians. • Directed   all   aspects   of   Quality   Assurance,   such   as   validations   (autoclaves   and   other  equipment, aseptic media fills), CGMP training, and auditing of contract test facilities • Responsible   for   managing   all   QC   activities,   such   as   the   operation   of   the   QC   laboratory,  including planning, test development, supervision of QC analysts, and approval of QC test  results • Implemented change control and deviation reporting systems • Established and implemented critical CGMP programs (raw materials and equipment control,  environmental monitoring program, in­house sterility testing, and stability testing) • Established Master Production Batch Records. Reviewed and approved all MPBRs, PBRs,  and SOPs. • Prepared and coordinated manufacturing, control, and other technical sections of regulatory  submissions (12 Type II Master Files and associated amendments) • Approved product for use in clinical trials  

MA Biologic Laboratories  Jamaica Plain, MA  1987 – 1992 A division of the Massachusetts Department of Public Health known as the State Laboratory  Institute,   Massachusetts   Biologic   Laboratories   provides   vaccine,   blood   products,   and  immunoglobulin   manufacture   and   testing   to   assist   in   disease   prevention   and   surveillance  statewide. Quality Control Supervisor/Chemist II Responsible for all aspects of compliance in a CGMP laboratory. Direct supervision of ten QC  technicians and administrative personnel. • Supervised Quality Control department • Responsibility for all aspects of Quality Assurance • Represented the Biologic Laboratories during FDA (US and Canada) and USDA visits • Supervised contract manufacturer activities for clinical and commercial products • Established and maintained stability testing program

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• Developed environmental monitoring program for the QC department • Validated the use of the Steritest system for performing sterility testing • Interfaced with Production and R&D to coordinate new process and equipment introduction

Boston VA Hospital  Boston, MA  1984 – 1986 Medical Research Assistant • Conducted infectious disease research (nosocomial infections of Staphylococcus aureus) • Performed and perfected assays (ELISA) to detect capsular polysaccharide and teichoic acid • Executed microbiological techniques

Education M.S. Medical Microbiology, Northeastern University B.A. Biology, Susquehanna University

Professional Affiliations Parenteral Drug Association Institute of Environmental Sciences and Technology International Society for Pharmaceutical Engineering