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David Ingamells

Senior Biologics Manufacturing Consultant

Dave is a technical operation executive and consultant with a very diverse background in biopharmaceuticals. A change agent with proven ability to transform teams, design and construct manufacturing facilities, and lead product development from process development through commercialization. Over a 30-year career, Dave managed Chemistry, Manufacturing and Control (CMC) operations staff, engineers, and development scientists; ranging up to 55 employees.

His Consultant experience includes:

• Built from the ground up, re-engineered, and managed several operations functions; Supply Chain, Bulk Manufacturing, Process Development
• Designed, constructed, commissioned, licensed, and managed facilities
• Significant expertise in manufacturing using mammalian and bacterial cultures, based upon batch-fed and perfusion technologies; Antibodies, Proteins, Enzymes, Viruses, Antibiotics
• Authored and reviewed CMC sections of BLAs, MAAs, NDAs and INDs

Dave began his career in manufacturing at GENENTECH and progressed to biological process R&D at Idec, Biomarin, and Optimer Pharmaceuticals. Dave joined DSI in 2020 from Vaxart as an expert biologics consultant whose career focus has evolved toward applying principles of quality risk assessment and sound science to provide CMC guidance to all aspects of biological process drug development. Dave holds a B.S. in Biochemistry Magna Cum Laude from San Francisco State University.