Senior Director, Regulatory Affairs at WuXi Biologics
Ken Chen has over 17 years of biopharma experience. Previously at Amgen for 10 years with increasing responsibilities specialized in CMC, analytical and quality. Later joined Guthy-Renker building the quality and regulatory systems. Joined WuXi Biologics in 2015 to establish the QC-SH team and global Regulatory Affairs team and contributed to 100+ global INDs, 1 US BLA, and 1 MAA approval.
He obtained a BS in Pharmaceutics from the SUNY at Buffalo and an MBA from University of Southern California.