- Vice President, Assembly Bioscience
Dr. Grandolfi has served as Vice President and Head of Chemistry, Manufacturing, and Controls (CMC) for Amarin Pharma Inc. since October 2008. He has more than 26 years experience in the pharmaceutical industry, most notably in the area of CMC product development. Prior to joining Amarin, Dr. Grandolfi held positions of increasing responsibility at Boehringer Ingelheim, DuPont-Merck, Cephalon, Alkermes, and Spherics Pharmaceuticals.
Dr. Grandolfi’s primary areas of interest and responsibility include drug substance and drug product development, analytical testing, manufacturing, scale-up, technology transfer, stability, packaging, and clinical trial materials management. He has led the development of clinical and commercial dosage forms (including tablets, hard gelatin capsules, soft gelatin capsules, lyophilized, parenterals, and depot injections) and has He authored the CMC sections of numerous regulatory submissions, including four approved New Drug Applications (Provigil®, Risperdal Consta®, Vivitrol®, and Vascepa®). Dr. Grandolfi routinely represents the CMC function for interactions with the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities. He has been an author of several scientific publications and presentations. In addition to his industry career, Dr. Grandolfi has been an instructor of undergraduate pharmaceutics courses at the Ohio State University. He has also been a member of the American Association of Pharmaceutical Scientists, American Oil Chemists Society, Controlled Release Society, and Parenteral Drug Association.
Dr. Grandolfi holds a B.S. in Pharmacy from the University of Rhode Island, a M.S. in Pharmaceutics from the University of Wisconsin–Madison, and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the Ohio State University. He is also a licensed pharmacist.