Kevin Zen, PhD

CMC Technical Operations at Opthea

Speaker

Kevin has served leadership positions developing therapeutic biological products at AbbVie, AnaptysBio, Catalent Biopharma Solutions, IGM Biosciences, and Opthea. Kevin not only has in-depth expertise in Analytical Development but also has broad experience in Biologics CMC technical operations, quality compliance and regulatory requirement. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience selecting and managing external CDMO and CRO. He was often invited to present seminars and offer training courses on bioprocessing, manufacturing, control strategies, analytical characterization, formulation, comparability, process and method validation in the international conferences. In his career, he has successfully submitted many biological drugs to IMPD/IND from early development to commercial.