James Warren

Dr. Warren has 29 years of experience in the development, manufacturing, and commercialization of gene therapy viral vectors and live viral vaccines, with applied focus on bioprocess development and CMC Development Strategy. At Ultragenyx, he leads a team of 80 scientists and engineers, responsible for all early- and late-stage Process and Analytical Development of AAV portfolio products as well as Pilot Scale Manufacturing in Woburn, MA. Before coming to Ultragenyx Jim held senior CMC leadership positions at Homology Medicines, bluebird bio, Shire, and Merck & Co., leading process development and manufacturing teams responsible for development of several clinical candidates as well as the licensure of RotaTeq®, Varivax®, ProQuad®, and Zostavax®. Dr. Warren holds BS/MS degrees in Biotechnology from William Paterson University and a PhD in Molecular and Cellular Biology from Lehigh University.