James Warren, Ph.D.

VP, Pharmaceutical Development, Ultragenyx

Dr. Warren has more than 25 years of experience in the pharmaceutical and biotechnology industry, with a focus in bioprocess development and manufacturing of viral vectors, viral vaccines, and biologics. At Ultragenyx, he leads a team of over 50 scientists and engineers, responsible for all early and late stage Process and Analytical Development of viral vector products as well as Pilot Scale Manufacturing in the Woburn, MA Pilot Plant. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, and Shire. Earlier in his career, Jim spent 16 years at Merck & Co., Inc., where he led process development, technology transfer, and manufacturing sciences teams responsible for development of several clinical vector and vaccine candidates and the licensure of multiple commercial vaccines (RotaTeq®, Varivax®, ProQuad®, and Zostavax®). Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a Ph.D. in Molecular & Cellular Biology from Lehigh University.