Xiaoyu (Sam) Hu, Ph.D.
Consultant
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.