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  6.  » Yunsong (Frank) Li, Ph.D.

Yunsong (Frank) Li, Ph.D.

YUNSONG (FRANK) LI, PH.D.
SENIOR DIRECTOR, PRODUCT DEVELOPMENT

Dr. Li joined Catalent Biologics following the acquisition of Cook Pharmica. He is the Senior Director of Product Development at Catalent Bloomington and leads the process, analytical and formulation development to meet client drug substance and drug product development needs. He also serves as Adjunct Associate Professor in The Department of Industrial & Physical Pharmacy at Purdue University teaching various classes to graduate students and pharmacy students the biopharmaceutical development. Prior to his current role, Frank worked at Merck & Co. in various roles including, group leader for analytical method development and high throughput testing, group leader for biophysical characterization and later served as the Associate Principal Scientist in formulation development at Merck in Kenilworth, New Jersey. He was responsible for formulation development and fill finish process development for Merck biologics including monoclonal antibodies, therapeutic proteins and antibody-drug conjugates. At Merck, he was also the technical lead on the drug product process compatibility studies and responsible for process transfer to internal manufacture sites and CMOs. In a previous role at Merck, he led the analytical team supporting formulation development, CGMP testing for release and stability studies. He also led efforts on the biophysical characterization for sub-visible particle analysis and protein higher order structure characterization. Prior to joining Merck, Frank worked for Amgen as a scientist responsible for late stage drug product development including formulation, fill finish process development and lyophilization scale-up. Frank has a Ph.D. in Pharmaceutical Chemistry from The University of Kansas, a M.Sc. in Chemistry from the University of British Columbia and a B.Sc. in Chemistry from Peking University in Beijing. He has published over 10 peer-reviewed publications.