Yang Gao
About Yang Gao
Yang Gao is the Senior Director and Head of Analytical R&D, CMC at BeiGene, with extensive experience in pharmaceutical development and regulatory submissions.
Company
Yang Gao is currently employed at BeiGene, where he holds the position of Senior Director, Head of Analytical R&D, CMC. His responsibilities include leading the analytical development for multiple clinical and commercial stage projects at the company. Under his guidance, the Analytical R&D team works on regulatory submissions and manages CRO/CMO for pharmaceutical development projects.
Title
Yang Gao serves as the Senior Director, Head of Analytical R&D, CMC at BeiGene. In this role, he oversees the analytical research and development efforts essential for the progression of clinical and commercial pharmaceutical projects. His team is responsible for implementing and managing control strategies, conducting stability studies, and performing method transfers for drug products.
Education and Expertise
Yang Gao earned his PhD in Analytical Chemistry from Purdue University, where he spent four years as a Graduate Research Assistant. He also holds a BS in Pharmacy from Peking University. Gao specializes in analytical techniques such as LC-MS/MS, GC-MS, LC-HRMS, SEC, IEX, and HILIC. He has expertise in bioanalytical method development and validation for DMPK studies, as well as experience with various analytical instruments including DSC, TGA, and IR.
Background
Yang Gao has had a progressive career across multiple organizations. Before his current role at BeiGene, he served as Director and Associate Director in the same company, focusing on analytical development in Suzhou, Jiangsu, China. Prior to that, he worked at Gilead Sciences as an Associate Director and Senior Manager in the San Francisco Bay Area. Gao’s early career includes functioning as a Staff Scientist at Covance in Madison, Wisconsin Area, and as a Graduate Research Assistant at Purdue University.
Achievements
Yang Gao has led the analytical development efforts for numerous clinical and commercial stage projects at BeiGene. His extensive experience includes regulatory submissions such as IND, IMPD, and NDA. Additionally, Gao has developed bioanalytical methods for DMPK studies and applied advanced analytical methods and instruments in pharmaceutical research. His strong background in PK/PD modeling and toxicology studies further contributes to his expertise.