Kok Seong Lim

Kok-Seong Lim, BPharm, PhD, RAC, is a pharmaceutical leader with over 20 years of experience in biological research and development, specializing in CMC, analytical sciences, quality control and regulatory strategy for advanced therapy platforms. He has held several leadership positions at Metagenomi, Aura Biosciences, Editas Medicine and Thermo Fisher Scientific, where he helped advance more than 15 advanced therapy programs spanning gene therapy, cell therapy, gene-editing technologies for a broad range of rare disease and oncology indications, such as hemophilia, retinal diseases and lysosomal storage disorders. His experience includes establishing GMP-compliant manufacturing facilities and analytical infrastructures to support products from early-stage development through late-stage clinical programs. He has managed multimillion-dollar portfolios and played a key role in regulatory submissions and interactions with health authorities in the U.S. and Europe. An active contributor to the biotechnology and regulatory communities, Kok-Seong currently serves as Chair of the Regulatory Affairs Professional Society San Francisco Chapter and as a member of the U.S. Pharmacopeia Biologics – Cell and Gene Therapy Expert Committee, where he collaborates with industry and regulatory experts to develop standards and best practices that advance the field of cell and gene therapy. Kok-Seong earned his PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde.