Dr. Ming Lei is a strategic and agile leader excel at enabling innovative solutions and forging meaningful connections. She has 15 years of experience working in the biopharmaceutical industry with a broad range of expertise in CMC for biologics and small molecules including process and analytical development, quality and regulatory. Currently, Ming serves as a senior manager in regulatory sciences at Gilead contributing to multiple projects spanning from early development, market application to post-approval stages. Prior to Gilead, Ming held various positions with increasing responsibilities at Genentech. In these positions, she led global cross-functional teams to achieve strategic project milestones and successful regulatory filings, authored innovative research and insightful review publications through internal and external collaborations, and spearheaded data digital transformation programs to enable effective decision-making. She is equipped with a proven track record in strategy development, project management and cross-functional team leadership. Extensive experience in CMC regulatory with multiple successful approval of BLA, NDA and PAS.
Ming has a passion for knowledge-sharing and mentoring. She serves as a member-at-large for Parental Drug Association- West Coast Chapter and has led several highly successful events. She founded biotech academy, a peer-to-peer discussion forum with high-quality content from leaders within the biotech industry. Ming also led highly participated mentoring programs thanks to clear goals and flexible structures. She is an active mentor in the ASP Development Coaching Programs for aspiring and under-served students and young professionals.
She holds a Ph.D. in Pharmaceutical Chemistry (honor) from the University of Kansas, a Master of Science degree in Analytical Chemistry from Indiana University, and a Bachelor of Science in Chemistry from Fudan University, China.