Karen A. Bossert Lyophilization Technology, Inc.

Karen joined Lyophilization Technology, Inc., in 2005 as Vice-President, Scientific Affairs, where she is responsible for scientific and technical direction for client projects and providing consulting services. She is responsible for all Quality aspects of clinical manufacturing, and is the primary Regulatory contact for the company. Karen is also a member of the Scientific Advisory Board, directing and overseeing internal research projects for the company.

Karen has over 20 years experience in pharmaceutical manufacturing that includes lyophilization and validation. She received her Bachelor of Science degree in Pharmacy at The Albany College of Pharmacy and her Doctorate in Pharmacy at The Philadelphia College of Pharmacy and Science.

Her experience in the pharmaceutical industry includes formulation and product development, validation, clinical manufacturing and parenteral production. She started her career in 1988 a senior research pharmacist at Sterling-Winthrop Research Institute in Rensselaer, New York. In 1989, she transferred to SmithKline Beecham Pharmaceuticals as Associate Sr. Investigator in Clinical Manufacturing Pharmaceutical Sciences. She held numerous positions at GlaxoSmithKline in the US and the UK, with her last position as Manager, Manufacturing Development for sterile products and bulk APIs. She then joined Regeneron Pharmaceuticals in 2000 as Director, Manufacturing, being responsible for commercial manufacturing. In 2002, she was promoted to Sr. Director, Quality Assurance.

Karen has authored and presented numerous papers and courses in freeze drying. She has been an instructor in the field since 1992 for The Center for Professional Advancement as well as the Institute for International Research, and the Parenteral Drug Association. Karen is an active member of American Association of Pharmaceutical Scientists, American Pharmaceutical Association, International Society for Pharmaceutical Engineers, International Society of Lyophilization-Freeze Drying, and the Parenteral Drug Association (PDA).