Shaoping Yang
About Shaoping Yang
Shaoping Yang is the Head of Technology Deployment Center of Excellence at Bristol Myers Squibb, with extensive expertise in GMP, FDA regulatory processes, and biopharmaceutical manufacturing.
Title
Shaoping Yang is the Head of Technology Deployment Center of Excellence at Bristol Myers Squibb. She is based in Warren, NJ.
Expertise in GMP and FDA Regulatory Processes
Shaoping Yang is an expert in Good Manufacturing Practice (GMP) and has extensive experience with FDA regulatory processes. Her expertise ensures that the products and manufacturing processes adhere to stringent regulatory standards, which is critical for maintaining the safety and efficacy of pharmaceutical products.
Professional Background
Before her current role at Bristol Myers Squibb, Shaoping Yang held various positions at GSK. She served as a Principal Engineer in Viral Vector Manufacturing, CGT R&D from 2017 to 2021 and in Biopharm R&D from 2010 to 2017, both in King of Prussia, PA. Prior to that, she was a Senior Scientist in Pharm R&D from 2004 to 2009. Additionally, she worked as a Senior Scientist/Supervisor at Catalent Pharma Solutions and as a Scientist at Omnicare Pharmaceuticals. Her early career began at Eurofins Lancaster Laboratories as a Senior Chemist.
Education and Credentials
Shaoping Yang earned her Doctor of Philosophy (Ph.D.) in Chemistry from Southern Illinois University, Carbondale, where she studied from 1992 to 1998. She also holds a Bachelor of Science (B.S.) in Chemical Engineering from Dalian University of Technology and a Master of Science (M.S.) in Biochemical Engineering from East China University of Science and Technology.
Process Development and Product Manufacturing Experience
Shaoping Yang has extensive experience in process development and product manufacturing, particularly for cell therapy and viral vectors. Her role involves critical tasks such as analytical science, technology transfer, and validation and characterization of manufacturing processes. She specializes in CMC (Chemistry, Manufacturing, and Controls), QbD (Quality by Design), and the use of Single-Use Technology (SUT) in manufacturing.
Leadership in Biopharmaceutical Industry
Shaoping Yang has significant experience leading matrix teams in project management and process validation within the biopharmaceutical industry. Her roles have included the deployment of cell and gene therapy technologies and the scale-up and characterization of biopharmaceutical products. She has a comprehensive understanding of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA), vital for ensuring product quality and efficacy.