Fenton Fong, MSc

CMC Development Lead


Novateur Advisor Since



CMC and Manufacturing/Process Development


Aseptic Processing, Biologics / C&GT, Cleanroom Design, Construction & Operation, CMC Supply Chain / Logistics & Procurement, CRO / CDMO / Material Vendor Selection & Management, Due Diligence / Gap Analysis Audits, Quality

"Playing a value-added role in advancing life science technologies for clients is my core passion."

Fenton Fong, MSc
CMC Development Lead

Fenton Fong is a seasoned CMC professional with 30 years of corporate work and consulting experience in Pharma, Biotech, and related industries. He has a deep understanding of application of GMP’s in different environments. Fenton’s career began at Raylo Chemicals with responsibilities in small molecule synthesis, lab & pilot-scale process development & manufacturing. His work expanded into molecular biology at UBC and published research in disorders of heme synthesis. After completing his MSc in industrial microbiology at the UBC Biotechnology Laboratory he served as a process development specialist at QLT and a principal CMC team member for preparation and writing of an NDA for a blockbuster parenteral product. Fenton has served in project teams for the design, construction and CQV of cleanroom manufacturing facilities and operations. His passion is biologics CMC and aseptic processing, fill/finish. He has conducted CMC review and evaluations of Cell & Gene Therapy manufacturing processes. His experience also includes roles as QA Manager for OTC contract manufacturer and a biopharmaceutical/sterile product manufacturer. Fenton has 10yrs of consulting experience with ~100 clients and numerous GMP/CMC-related projects spanning domestic & international sites in Asia, EU, USA & South America. Fenton serves as an Editorial Board member (JPST) for PDA.

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