Karen A. Bossert, PhD, RPh, Vice President, Scientific Affairs, 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
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).
Barbara Berglund, PhD, CQM/OE, Director of Health Services
Barb Berglund has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 15 years. Her experience includes her current role as a Quality Partner as well as strategic leadership roles in the laboratory, project management, and clinical trial manufacturing. While in project management and manufacturing, she gained direct hands-on knowledge of development stage, clinical trial, and commercial scale lyophilization of active ingredients and finished pharmaceuticals. She managed QC groups responsible for analytical procedure transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.