United States
Led the strategic planning and execution of CMC activities for the company’s advanced biologics and cell therapy pipeline. Managed a portfolio of complex projects, ensuring all development and manufacturing processes meet stringent global regulatory standards and business objectives Successfully led the CMC development for commercialization of the CAR-T product (Kymriah®), addressing critical manufacturing scalability and quality control challenges to support its global supply chain Developed and implemented a data-driven CMC risk management framework using multivariate data analysis (MVDA), which significantly improved process robustness and reduced project-level risk by 30% Pioneered a strategic collaboration with a leading biotech firm, culminating in a successful technology transfer and a multi-million dollar partnership to advance our cell therapy platform Served as a key company representative at major international conferences, presenting on innovations in biologic manufacturing and regulatory compliance to enhance corporate reputation
Directed a team of over 30 scientists and engineers, overseeing end-to-end process and formulation development for multiple therapeutic areas, with a key focus on gene and cell therapies Assumed full responsibility for the process and formulation development of a novel AAV-based gene therapy, successfully guiding the project from the concept phase to the clinical trial application ahead of schedule Restructured the team into specialized technical groups focusing on high-risk areas like lipid nanoparticle (LNP) delivery systems, significantly enhancing the team's overall technical capability Established strategic partnerships with external innovators to integrate new high-throughput screening technologies, which accelerated formulation development cycles Provided critical technical and risk-based insights to executive leadership during quarterly review meetings to support R&D investment decisions
Managed a cross-functional team responsible for translating drug substance into final injectable and infusible drug products. Key responsibilities included formulation, fill/finish process design, and stability studies