Bill Hunke is a product development consultant, currently providing consultation to the Pharmaceutical Industry on the formulation, development and manufacture of Sterile and Liquid products. His expertise includes sterile and liquid product formulation design and development, product package assessment, and manufacturing process development.
Bill recently retired from Merck & Co., where he was a Director of Sterile and Liquids Commercialization. While at Merck, he headed up the late stage development, clinical manufacture, and commercialization of new liquid and injectable products; including numerous pharmaceutical, biological and vaccine products. Prior to that, Dr. Hunke was Director of Sterile Products at Sterling Winthrop/Sanofi (Rensselaer, NY/Collegeville, PA). Within Sterling/Sanofi he held various technical management positions; including liquid and sterile formulation and development, clinical supplies manufacturing, and served as a development project team leader. Bill is a registered Pharmacist, with a BS in Pharmacy from North Dakota State University; and he holds a Ph.D. in Pharmacy (Pharmaceutics) from the University of Iowa.
He is a member of the Parenteral Drug Association (PDA) and the American Association of Pharmaceutical Scientists. Within the PDA bill has been active in the Packaging Science Research and Lyophilization Interest Groups. He recently was a member of the PDA planning committee for the PDA Extractables and Leachables Forum, and served as a session chair during the forum. Bill has authored and presented numerous papers on the development, evaluation, and manufacturing of a variety of sterile and liquid products. He also holds several US Patents.