Sheena Hailin Wang

Dr. Sheena Hailin Wang is a lead pharmaceutical scientist at FDA’s Center for Drug Evaluation and Research (CDER), where she supports quality and manufacturing oversight of biologic products including biosimilars across product lifecycle. She has contributed to the development of FDA guidance on visual inspection of visible particulates in injectable products. Dr. Wang is a member of the Visible and Subvisible Particulate Matter Expert Committee of the United States of Pharmacopeia. Prior to joining FDA in 2013, Dr. Wang worked in the biopharmaceutical industry supporting viral vaccine development and manufacturing. This dual perspective enables her to bridge regulatory expectations and practical implementation of quality principles in biologics manufacturing. Dr. Wang holds a Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill.