KS Lim

Company: No Company

Job title: Senior Director, Analytical Sciences & Quality Control

Bio:

Kok-Seong Lim, BPharm, PhD, is a pharmaceutical leader with over 20 years of experience in biological research and development, specializing in analytical sciences, quality control, and CMC strategy for advanced therapy platforms. He has held multiple management roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific (formerly Brammer Bio), where he contributed to the advancement of more than 10 gene therapies and CRISPR-based medicines for rare diseases and oncology indications.

Throughout his career, Kok-Seong has led the buildout of GMP-compliant facilities and analytical infrastructures to support early- and late-stage development. He has successfully managed complex, multimillion-dollar budgets and contributed to regulatory submissions in both the U.S. and EU. An active industry contributor, Kok-Seong regularly presents at conferences and has served on committees such as the U.S. Pharmacopeia Biologics Stakeholder Forum and the Standards Coordinating Body, helping to shape best practices and standards for the cell and gene therapy field.

He earned his PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde.

Seminars:

Panel Discussion: Shaping the Future of Ancillary Materials in Cell & Gene Therapy Insights from ISO Standard Development 9:00 am

Firsthand experience contributing to a new ISO standard, focused on ancillary materials used in advanced therapies Overview of the U.S. TAG validation process and transition to a New Work Item Proposal within the ISO framework What this upcoming standard means for developers, manufacturers, and regulators over the next 3 to 4 yearsRead more

day: Conference Day Two

Roundtable Discussion: Defining the Right Material Attributes for Consistency & Control in Cell & Gene Therapy Manufacturing 11:45 am

Identifying all properties that need to be assessed when testing a raw material for use in cell and gene therapy Developing the knowledge of distinguishing between critical and non-critical attributes based on risk and functional relevance How to create a robust plan of attribute to be tested in a new raw materialRead more

day: Conference Day Two