Industry Experts

James Warren is a seasoned biopharma executive with 30 years of experience advancing innovative medicines to improve global human health. He currently leads Global CMC Development at Ultragenyx, overseeing early and late-stage Process Development & Scale-up, Analytical Development, and Product Characterization. His teams in Woburn, MA and Brisbane, CA support a diverse rare disease portfolio spanning gene therapies, biologics, antisense oligonucleotides (ASOs), and small molecules.

Jim is an accomplished cross-functional leader with a broad background in both early and late-stage development across vaccines, viral vectors, oligonucleotides, and biologics. He has successfully driven critical paths to licensure for multiple therapeutic modalities through sound science, clear strategy, and collaborative leadership.

Jim holds BS/MS degrees in Biotechnology from William Paterson University and a Ph.D. in Molecular & Cellular Biology from Lehigh University.