Sharon Gao PhD
Sharon Gao has served as our Vice President of Chemistry, Manufacturing and Controls since November 2021. She brings over 20 years of experience in the biotechnology and pharmaceutical industries supporting R&D, accelerated CMC development with phase-appropriate strategies, and regulatory filings. Prior to Bright Peak, Sharon worked at Synthrox, later known as Sanofi San Diego upon the company’s acquisition. At Synthrox/Sanofi, Sharon oversaw CMC analytical and formulation development, drug product manufacturing, GMP test release and stability for the Company’s IL-2 immuno-oncology program. She played a crucial role in correspondences to Health Authorities and actively participated in Type C meetings with FDA. Previously, Sharon was a senior director at La Jolla Pharmaceuticals where she oversaw the analytical development of a peptide drug candidate in Phase 1-2 and supervised QC release and stability for the phase 1 drug product. Sharon also participated in pre-approval inspection for the commercial launch of Giapreza. Before joining La Jolla Pharmaceutical, Sharon was the head of Analytical Chemistry and Quality Control at Quidel (formerly known as Alere Inc.), where she established the GMP testing and quality control facilities and supervised validations to support quality investigations and manufacturing. From 2005-2012, Sharon and her teams assessed the developability of monoclonal antibodies, multi-specific antibodies and pegylated proteins. Sharon received her PhD in Analytical Chemistry from the University of California, San Diego and completed post-doctoral training at Washington University in St Louis.