Shawn Kinney

Shawn Kinney, PhD

Consultant

Dr. Shawn Kinney is an experienced senior executive and consultant with a technical background and more than 40 years of experience in sterile drug product manufacturing. He co-founded Berkshire Sterile Manufacturing (BSM), and played a pivotal role in growing the company from just 3 employees in 2014 to over 240 by 2024 when he retired.

Prior to establishing Berkshire Sterile Manufacturing, Inc. (BSM), Dr. Kinney founded and led a sterile drug product drug contract manufacturing company, which was purchased by AMRI, now Curia. Prior to that, he was the Vice President of Operations at medical products company where he was responsible for sterile fill/finish of viscous medical devices and drug products in pre-filled syringes.

Dr. Kinney started his pharmaceutical career as a sterile fill operator in the mid 1980’s and advanced his career through positions in Quality Control, Quality Assurance and Operations in the pharmaceutical industry. He is responsible for the flexible high quality aseptic isolator-based manufacturing organization at BSM that supported clinical scale and smaller volume commercial sterile manufacturing. In October 2023, BSM was acquired by Sharp. Dr. Kinney continues to lead BSM, now a subsidiary of Sharp, as the President of the Sterile Division.

Dr. Kinney is a long-time member of the Parenteral Drug Association (PDA). He has Co-Chaired the Pre-Filled Syringe Conference and given numerous presentations at the PDA Pre-Filled Syringe and other Pre-Filled Syringe Conferences. Dr. Kinney has also participated in glass handling and Pre-Filled Syringe task forces.

Dr. Kinney holds a Doctorate in Chemistry from the University of Massachusetts at Amherst, an MS in Medicinal Chemistry from Northeastern University and a Bachelor of Science from Southeastern Massachusetts University, now UMass Dartmouth.