John Geigert, Ph.D.

John Geigert, Ph.D., RAC is President of BioPharmaceutical Quality Solutions, in San Diego, California, which for over 15 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry (recombinant proteins, monoclonal antibodies), and now for the advanced therapy products (gene and cellular therapy).

Dr. Geigert has over 35 years of experience within the biopharmaceutical industry developing and implementing CMC regulatory compliant strategies for biopharmaceuticals. He has 10 years Executive Management experience as Vice President, Quality & Executive Officer at IDEC Pharmaceuticals, and Vice President, Quality at Immunex.

He has served on the PDA Board of Directors and chaired the PDA Biopharmaceutical Advisory Board.  Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 3^rd Edition.

Courses:

• CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics
• CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines