James Warren, Ph.D.

Senior VP, Global CMC Development at Ultragenyx Pharmaceutical Inc.

Speaker

Jim leads Global CMC Development at Ultragenyx, responsible for all early and late-stage Process Development & Scale-up, Analytical Development & Product Characterization, driving a diverse rare disease portfolio of gene therapy, biologics, ASOs, and small molecule products in Woburn, MA and Brisbane, CA sites. Previously, 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 contributing to 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.