Xiaoyu (Sam) Hu, Ph.D.

Xiaoyu (Sam) Hu, Ph.D.

Dr. Xiaoyu “Sam” Hu is a biopharmaceutical Technical Operations and MSAT leader with extensive experience spanning gene and cell therapy, viral vectors, vaccines, virus-like particles (VLPs), and conjugated biologics. His expertise includes technology transfer, process characterization and validation, PPQ and commercial readiness, CDMO oversight, manufacturing troubleshooting, and lifecycle CMC strategy. At Aura Biosciences, he led sponsor-side process validation strategy for a late-stage conjugated VLP therapeutic across a multi-CDMO manufacturing network and established the company’s lifecycle process validation framework. Previously at Novavax, he led global PPQ and validation strategy across more than eight CDMOs supporting commercial vaccine supply and regulatory approvals or authorizations in more than 40 countries, and served as a Drug Substance technical and BLA lead for validation and manufacturing content. Earlier at Lonza, he led

technology transfer of more than 10 viral-vector programs into GMP manufacturing, including one program that advanced to commercial manufacturing, while providing MSAT leadership for GMP campaigns, investigations, troubleshooting, CAPA, and continued process verification. Dr. Hu brings experience from both sponsor and CDMO perspectives and has partnered cross-functionally with Quality, Regulatory, Process Development, Manufacturing, and Supply Chain organizations. He holds a Ph.D. in Biomedical Genetics from the University of Rochester Medical Center.