BioPharmaceutical Quality Solutions
John Geigert, Ph.D., RAC, President, BioPharmaceutical Quality Solutions, a consultant for the past 10 years specializing in CMC regulatory strategy for the biopharmaceutical industry.
Dr. Geigert has held senior leadership positions in industry as Vice President of Quality for both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and as Director of Quality Control for Cetus Corporation in Emeryville, CA. He obtained his B.S. in Chemistry from Washington State University, and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.
Dr. Geigert has been a major participant in CMC regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe, and has over 30 years of experience in the biopharmaceutical industry.
He is author of the book, The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, Plenum Press, New York (2004) and has written articles for RAPS, What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products; 4-part series in RAPS Focus; Aug-Nov 2009.