Yen Cu

Yen Cu, PhD, is a seasoned pharmaceutical professional with extensive experience in formulation development and CMC program leadership. Currently serving as Sr Director and CMC Program Lead at Ultragenyx Pharmaceutical Inc., Yen Cu leads cross-functional teams for small molecule and ASO programs. Prior roles include Research Scientist II at Amneal Pharmaceuticals, where Yen Cu managed R&D and GMP manufacturing activities for generic OSD products, and Senior Scientist at Kala Pharmaceuticals, contributing to the successful filing of ophthalmic suspensions. Earlier career experiences include work as a Junior Scientific Investigator at Novartis Vaccines and Diagnostics, focusing on HIV vaccine formulations, and as a Teaching Fellow at Yale University. Educational qualifications include a PhD in Biomedical Engineering from Yale University, as well as multiple professional certificates and degrees in genetics, genomics, medical statistics, and biological engineering from prestigious institutions.