GMP Manufacturing and QA Compliance Management
GMP Manufacturing / QA Compliance Management / Audits / Gap Analysis / Regulatory Compliance Technology Transfer / Process Engineering / Scale-Up / GMP Facility Design / Construction Management
Highly accomplished GMP manufacturing and QA compliance management professional with a comprehensive and successful track record. Assures compliance with all applicable U.S., E.U. and Canadian regulatory requirements. Has conducted worldwide compliance audits to ensure strict adherence to all current GMP, GLP, ISO, ICH and aseptic processing guidelines. Has assisted in the preparation of CMC sections of regulatory submissions (IND, NDA, ANDA, BLA and CTA). Has managed the construction, opening and operations of a network of GMP manufacturing and aseptic processing facilities of varying degrees of complexity. Comprehensive background in manufacturing process development, systems and team development, formulating business strategy, budgetary planning, financial management, and directing complex business transformations, projects, and initiatives consistent with established goals, objectives, and timelines.
• Directed GMP manufacturing and operations in multiple biotech and pharmaceutical organizations.
• Devised and executed strategies to streamline operations, increase efficiency, and improve quality.
Key Skills:
Oustanding interpersonal, communication, team motivation, organizational, planning, analytical, problem solving and conflict resolution skills. Creative team leader with strong commitment to excellence and integrity.
SELECTED ACHIEVEMENTS
• Conducted worldwide (U.S., E.U., S.A., Canada) compliance audits to ensure strict adherence to current GMP, GLP, ISO (9001, 13485, 13408), ICH and regulatory guidelines and compliance with 21 CFR-Parts 210/211 (Finished Pharmaceuticals), Part 820 (Medical Devices) & Part 20 (APIs).
• Performed regulatory, accrediting agency and GMP pharmaceutical manufacturing audits to identify and remedy process deficiencies and compliance gaps and to insure adherence to all pertinent GMP manufacturing and aseptic processing guidelines and standards.
• Directed internal and outsourced commercial GMP manufacturing effort and long-term production strategy. Initiated manufacturing planning programs and process improvements.
• Created a network of GMP manufacturing and aseptic processing facilities across the U.S. by managing design, construction, opening, and start-up operations including cell culture, purification, process development/engineering, commissioning, scale-up, final formulation, and fill/finish.
• Established and directed company operations including feasibility studies, strategic planning, conceptual design, launch, production management, product distribution and service delivery activities of multiple early stage and established biotechnology and pharmaceutical organizations.
• Coordinated cross-functional management team activities of R&D, process engineering, QA/QC, regulatory affairs, clinical operations, medical affairs, and sales & marketing divisions of multiple companies to align operating strategies with overall corporate objectives.
• Maintained optimum staffing levels by recruiting, selecting, hiring, training, developing, and retaining employees. Implemented training programs to ensure compliance with GMP pharmaceutical manufacturing and aseptic processing guidelines and regulatory, quality, and safety standards.
• Saved over $4 Million annually by instituting cost-reducing purchasing practices, materials management, and inventory control programs. Negotiated contracts for the lease and purchase of equipment, outsourced contract GMP manufacturing, kit assembly, storage, and distribution services.
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PROFESSIONAL EXPERIENCE
Director of Operations & Quality, Akron Biotechnology, LLC, Boca Raton, FL 2008-2009
Innovative biotechnology company focused on providing its worldwide customers best-in-class cell culture products for
superior Research and Product Development.
• Developed, implemented and maintained a Quality System and Quality Manual including QA plans, programs, policies, documents, records and SOPs.
• Managed the development of an ISO-9001:2000 (Quality Management System) & ISO-13485:2003 (Medical Devices System).
• Led the design phase of a new state-of-the-art GMP manufacturing facility and ancillary analytical and quality testing laboratories.
• Coordinated cross-functional team activities of multiple divisions within the company.
• Directed all in-house and outsourced GMP production and oversight of all QA/QC, supply chain, shipping & receiving and product distribution operations.
• Managed the development and production of a mission-critical GMP cell cryopreservation product.
Consultant, J. D. Cascio & Associates, Ft. Lauderdale, FL 2002 – 2008
Serves FDA regulated biologics, biotechnology, pharmaceutical and hospital industry clients.
• Conducted worldwide (U.S., E.U., S.A., Canada) compliance audits to ensure strict adherence to current GMP, GLP, ISO (9001, 13485, 13408), ICH and regulatory guidelines and to ensure compliance with 21 CFR - Parts 210 & 211 (Finished Pharmaceuticals), 820 (Medical Devices) & 20 (APIs).
• Provided assistance with GMP manufacturing and quality issues, GMP facility design and construction management, project management, regulatory compliance, audits, and technology transfer activities.
• Assisted with contract negotiation, equipment acquisition, materials management, and inventory control.
• Collaborated with other consultants and industry experts, as needed, to devise client solution strategies.
Director of Operations, Theseus Imaging Corporation, Boston, MA 1998 – 2002
$15 Million provider of nuclear medicine radiopharmaceutical imaging products and services.
• Directed outsourcing of GMP manufacture of product kit components, kit assembly, storage, and distribution to clinical investigational sites in the U.S., E.U. and Canada.
• Developed and managed capital expenditure and business operations budgets, timelines, corporate business strategy, and tactical level plans. Managed budgets to $15 MM and staff of 25.
• Organized resources needed to launch construction, opening, and operations of a GMP production facility at key outsourcer to manufacture mission-critical kit component not available commercially.
Director of Operations, Chimeric Therapies, Inc., Sharon Hill, PA 1996 – 1998
Start-up biotech firm engaged in cellular therapy ...
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