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Biologics and Vaccines Practice Leader |
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Dr. Gerson is Biologics and Vaccine Practice Leader for Trusgen. He has more than 23 years of experience in the pharmaceutical and biotechnology business, with a focus on the establishment, design, construction and operations of large-scale manufacturing facilities in the U. S. and Canada.
Dr. Gerson served as COO and President of the Technology and Manufacturing Division, Celltrion, Inc., Incheon, Korea. Celltrion is a contract manufacturer of mammalian cell produced protein biopharmaceuticals. He was responsible for Manufacturing, QA, QC, Regulatory Affairs and Operational Services, with approximately 250 employees. Dr. Gerson guided Celltrion from the mechanical completion of a 50,000L facility for mammalian cell culture, through validation, start-up, tech-transfer of abatacept from BMS, and a highly successful Pre-Approval Inspection with zero ‘483’ observations.
Prior to joining Celltrion, Dr. Gerson spent 3 years at the International AIDS Vaccine Initiative (JAVI) as the Managing Director of Manufacturing. His career also includes 3 years at Acambis as the Vice President of Manufacturing and Development, and a 7-year tenure at Wyeth-Lederle Vaccines and Pediatrics as the Managing Director of Vaccine Manufacturing.
Throughout Dr. Gerson's career, he has been involved in the process development and manufacturing of numerous pediatric and adult vaccines against major infectious diseases. This includes the development of the manufacturing process for a new smallpox vaccine, and the manufacturing of the U.S. supply of polio, pertussis, diphtheria, tetanus and pneumonia. Dr. Gerson was also responsible for manufacturing vaccines, including the Sabin/Salk polio vaccines, for Canadian, PAHO and WHO-EPI vaccine programs. Dr. Gerson holds a Ph. D. in biology from McGill University and a B.S. in chemistry from the University of Western Ontario. |
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Donald F. Gerson, Ph.D. |
