Mark Panek
About Mark Panek
Mark Panek is the Director of Analytical Development & Testing at Bristol-Myers Squibb and the Head of the bio-comparability committee at Janssen Inc., with extensive experience in the pharmaceutical industry.
Title and Current Positions
Mark Panek holds the title of Director; Analytical Development & Testing. He is currently working at Janssen Inc. as the Head of the bio-comparability committee in Malvern, Pennsylvania. Additionally, he serves as the Director of Analytical Development & Testing at Bristol-Myers Squibb in Princeton, New Jersey, working in the Syracuse, New York area.
Previous Experience
Mark Panek has a rich history in the pharmaceutical industry. He worked at Johnson & Johnson Pharmaceutical Research and Development as a Principal Scientist from 2010 to 2012. Before that, he held positions at Bioanalytical Characterization Pharmaceutical Development Centocor R & D: Principal Research Scientist from 2008 to 2010 and Senior Research Scientist from 2004 to 2008. His early career experience includes a role as Senior Project Scientist - Laboratory Technical Support at Merck MMD from 2000 to 2004.
Educational Background
Mark Panek completed his Ph.D. in Chemistry at Penn State University, studying from 1993 to 2000. Prior to that, he earned his B.S. in Chemistry from the University of North Carolina at Chapel Hill, where he studied from 1989 to 1993.
Expertise and Committee Leadership
Mark Panek has significant expertise in writing biologic licensing applications, marketing authorization applications, and investigational new drug applications. He directly interacts with health authorities, prepares responses to their questions, and writes briefing books for scientific advisory meetings. Panek leads a committee responsible for reviewing and approving comparability strategies for large molecule products at Janssen Inc.
Technical Knowledge and Skills
Mark Panek possesses a clear understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and International Council for Harmonisation (ICH) guidelines. His expertise includes comparability, stability, process characterization, and process validation studies for protein therapeutic molecules.