John Geigert, Ph.D.

Specialties: Regulatory, Biotechnology, Management

John Geigert, Ph.D.

John Geigert, Ph.D., RAC, is President of BioPharmaceutical Quality Solutions, which for the last 12 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.

Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development for Cetus Corporation in Emeryville, CA. At these companies, he led the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products (4 recombinant proteins and 2 monoclonal antibodies) now commercially available in the U.S. and Europe.

He has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board, and served as an expert member of the USP Biotechnology Committee.

He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.

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Dr. Geigert is the author of the book The Challenge of CMC Regulatory Compliance For Biopharmaceuticals (and Other Biologics), with the 2nd edition released in 2013. He has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus: "What Senior Management Needs to Know About CMC Regulatory Compliance For Biotech Products" (Aug-Nov 2009, 4-part series); "Demystifying CMC Regulatory Strategy" (Sept 2011-Mar 2012, 4-part series).