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Jay Stout, Ph.D.

Sr. Consultant

Dr. Stout is an industry veteran with 25 years of experience in the development and commercialization of biologics. He has led organizations in the supply of clinical and commercial materials in immuno-oncology, vaccines, and cell therapy. His experience includes process scale up of microbial and mammalian biologics, tech transfer, process optimization, and post approval process modifications. Dr. Stout has served as Senior Vice President of Technical Operations at Versartis and San Bio, where he led the process development, manufacturing, and quality assurance groups supporting the development of an innovative long acting growth hormone and a stem cell therapy for patients following a stroke. Prior to San Bio, Dr. Stout served as Global Process Team Lead at Amgen for Enbrel, an anti-TNF product, and as Global Technical Lead at Merck for Keytruda (pembrolizumab), which was the first anti-PD-1 therapy approved in the United States and was awarded Breakthrough designation. Previously, he served as Executive Director of Merck’s Center for Biopharmaceutical Manufacturing and was Technical Lead on the Merck BioVentures leadership team, and was Executive Director of Amgen’s Manufacturing Sciences and Technology Group. Earlier in his career he started and directed Pfizer’s Biologics Development Group. Dr. Stout earned a Ph.D. in Chemistry and Biochemistry from the University of Nebraska-Lincoln, and a BS and MS in Chemistry from the University of Iowa.