William Bennett, M.S., B.S.
Engineering & Manufacturing Specialist
William Bennett, M.S., B.S. - Engineering & Manufacturing Specialist
Qualifications
Twenty-five years in CMC development, scale-up and manufacturing operations. Hands-on and managerial experience in all aspects of process development, from early lead production to commercial plant design, startup and validation. Extensive experience in licensing and contract development. Broad experience in materials sourcing/supply chain development, including commercialization of new items of commerce. Experienced in preparing CMC regulatory documents for INDs, IMPDs, NDAs, MAAs and DMFs. Broad experience in managing global projects and achieving effective international collaborations.
Work History
| 2008 - Present | Senior Consultant |
D.H Gold Associates, Inc. |
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Specializing in assisting companies by guiding drug development programs and preparation of clinical trial materials. Prepare chemistry, manufacturing and controls documentation for filing submissions. |
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| 2002 - 2008 | Vice President, Pharmaceutical Development & Manufacturing |
Keryx Pharmaceuticals, Inc. |
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Responsible for 8 pharmaceutical development programs for oncology and diabetes-related drugs. Active Ingredients included small molecules, natural products, and a chemically derivatized fermentation product. Drug products included sterile injectibles, film-coated tablets, hard and soft gelatin capsules as well as novel formulation prototypes.
Drug product development managed through CROs. Built a plant for commercial production of Phase III compound. Responsible for compliance of all CMC operations, preparation of CMC sections of regulatory submissions and of responses to CMC questions from regulatory authorities worldwide. |
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| 1996 - 2001 | Supervisor and Manager, Quality Control |
BASF/American Home Products (now Wyeth) |
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Strategic, tactical and technical leadership of multi-functional department of about 70 accountable for inventing, optimizing and developing chemical and biochemical process technology providing plant startup and other technical support to manufacturing. |
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| 1994 - 1996 | Manager, New Products, Manufacturing, International Ag. Division |
American Home Products (now Wyeth) |
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Development and scaleup of biological products. Troubleshoot technical and sterility issues in commercial manufacturing. Helped write CMC sections for NADAs as well as pioneering INAD for new drug derived from recombinant organism |
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| 1989 - 1994 | Group Leader, Process Development |
American Cyanamid Company, Agricultural Research Division |
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Technical/administrative oversight development and scaling up of processes. Responsibility encompassed technical, operational and process safety oversight of commercial startups both in-house and at contractors as well as preparation of CMC regulatory documents. |
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| 1987 - 1989 | Program Coordinator, Biochemical & Internations Process Development |
American Cyanamid Company, Agricultural |
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Development and scaleup of biological products. Troubleshoot technical and sterility issues in commercial manufacturing. Helped write CMC sections for NADAs as well as pioneering INAD for new drug derived from recombinant organism
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| 1984 - 1987 | Research Chemical Engineer, Process Development |
American Cyanamid Company, Agricultural |
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Education
| 1985 | M.S., Chemical Engineering |
Rutgers University Magna Cum Laude |
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| 1983 | B.S., Chemical Engineering | Rutgers University Summa Cum Laude |
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| 1974 | BA English, Teaching Certification |
Princeton University Cum Laude |
Professional Organizations
- Parenteral Drug Association (PDA)
- International Society of Pharmaceutical Engineers (ISPE)
- American Institute of Chemical Engineers (AIChE)
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