Cleaning Validation Master Plan

Terry O. Moore

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

Professional Experience Histogenics Corporation Waltham, MA 2008 A tissue regeneration company developing breakthrough treatments for long-lasting 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 Pre-Approval inspections • Approve and release final APIs • 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 privately-held 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 Pre-License Inspection • Implemented personnel and job-specific 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. 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

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• 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 (Pre-IND 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 • 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

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• Implemented change control and deviation reporting systems • Established and implemented critical CGMP programs (raw materials and equipment control, environmental monitoring program, in-house 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 • 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