Autor/-in: John Geigert

John Geigert, Ph. D. , RAC is President of BioPharmaceutical Quality Solutions, in Carlsbad, California. He has 50 years of experience within the biopharmaceutical industry developing Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategies for recombinant proteins, monoclonal antibodies, biosimilars, gene therapy vectors, and cellbased medicines. Dr. Geigert has 10 years Executive Management experience as Vice President, Quality & Executive Officer at IDEC Pharmaceuticals, and Vice President, Quality at Immunex. He now has served for 25 years as an international independent CMC regulatory compliance consultant. He is a past chair of the PDA Biopharmaceutical Advisory Board. Dr. Geigert is also the author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 4th Edition (June 2023).