Frank Highsmith

Frank Highsmith is an accomplished professional with extensive experience in quality assurance, engineering, and process validation within the biotechnology and pharmaceutical industries. Currently serving as Director of QA Validation at Regeneron since March 2024, Highsmith previously held the position of Director MSAT at Genentech from August 2011 to February 2024, where responsibilities included overseeing technology transfers and ensuring successful plant start-up and licensure. Highsmith also served as Director of Engineering at Bayer from January 1997 to July 2011, leading initiatives in process validation and budget management. Earlier experience includes a role as Biochemical Engineer at Merck, focusing on technology transfer and facility startup, and as Senior Process Engineer/Pilot Plant Manager at The Bionetics Corp., responsible for pilot plant redesign and technology transfer. Highsmith holds a Bachelor of Science degree in Chemical Engineering from the University of Maryland.