• Led tech transfer of multiple biological processes (CHO-K1, C1F and NS0 cell lines) from lab-scale to commercial manufacturing in single-use and stainless steel bioreactors

• Designed bench- and pilot-scale experiments to confirm/optimize process performance and yield; oversaw execution of experiments by junior team members; presented analysis and recommendations to cross-functional teams

• Prepared and executed multiple new product introduction in single-use and stainless steel production suites, including process flow design, production method, facility/equipment requirement, and raw material qualification/introduction/design

• Managed single-use production suite GMP readiness including process flow design, equipment/material/personnel flow, facility construction, equipment URS/DQ/IQ/OQ; completed GMP readiness within approved budget and timeline

• Evaluated new bioprocessing technologies and conducted experiments to assess feasibility; collaborated with vendors to customize equipment/single-use consumables and managed equipment introduction

• Created a data base for inventory tracking which decreases material transaction wait time by 20%; designed multiple document templates which eased process data collection and analysis

• Primary technical liaison between Beijing and Richmond sites supporting process development, manufacturing, and regulatory affairs

• Prepared common technical documents and filing documents for 2 new drug introduction filings for FDA and NMPA

• Conducted deviation investigation, report writing, and CAPA execution

• Authored and reviewed 15+ equipment qualification protocols, 20+ standard operating procedures, 50+ master production records (cell culture, purification, fill and finish, and packaging)

• Trained and provided real-time technical support for operators on single-use and stainless steel production process, including cell banking, cell culture expansion in shake flask, WAVE, and stirred-tank bioreactors up to 1000L, and cell harvest