Barry A. Friedman, Ph.D., is a Consultant in the Biotechnology, Regulatory Compliance, and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations, and fermentation technology.
Before becoming an independent consultant, Dr. Friedman was associated with Cambrex BioSciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty-one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry, and QC compliance for the production of Phase 1, 2, 3, and commercial products manufactured from bacteria, yeast, and mammalian cells. In this capacity, Dr. Friedman enjoyed many clients and regulatory interactions, both domestic and international.
Before 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid, and Union Carbide.
Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his Ph.D. from Ohio State University in Microbiology.