Biography

In 2021, Dr. Grandolfi retired from a successful 33-year career in the pharmaceutical industry, most notably in the functional areas of chemistry, manufacturing, and controls (CMC). 

Prior to joining the URI PDI, Dr. Grandolfi served as Vice President, Drug Product Development at Assembly Biosciences, where he led the development activities for microbiome therapeutics.  Previously, he was Vice President, CMC at Amarin Pharma.  Dr. Grandolfi has also held positions of increasing responsibility at Boehringer Ingelheim, DuPont-Merck, Cephalon, and Alkermes.  Dr. Grandolfi’s primary areas of interest and responsibilities have included drug substance and drug product development, clinical manufacturing and packaging, analytical testing, stability, scale-up, technology transfer, 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 authored the CMC sections of numerous regulatory submissions, including four approved New Drug Applications.  Dr. Grandolfi has routinely represented the CMC function for interactions with the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities. 

In addition to his industry career, Dr. Grandolfi currently serves on the External Advisory Board for the University of Rhode Island College of Pharmacy, and he has been an instructor of undergraduate pharmaceutics courses at the Ohio State University.  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.