Yan Li
Senior Director, Process Development, Manufacturing Science & Technology Cabaletta Bio
Yan Li is Senior Director, Process Development at Cabaletta Bio. She has extensive experience in Process Development, MS&T, GMP manufacturing, and regulatory strategy, leading cross-functional teams to advance cell therapy programs from development toward commercialization. Her work includes IND, CTA, BLA authoring, process characterization, PPQ, CDMO oversight, and next-generation manufacturing innovation. She has delivered automated, scalable, and robust CAR-T processes and supported global regulatory interactions. Yan holds a Doctor of Philosophy (PhD), Immunology and Molecular Virology & Bioengineering from Nanjing Agricultural University.
Seminars
- Discussing lessons learned across process optimization, and regulatory alignment to streamline manufacturing and reduce risk
- Leveraging manufacturing strategies to accelerate commercialization and ensure consistent, reliable delivery of therapies