JVL Pharma Consulting LLC
Principal
John Lepore is an industry consultant specializing in small molecule process development, development quality systems, and regulatory strategy. Prior to his retirement from Merck (MSD) John Lepore was CMC and QbD practices lead for small molecules and led API process development for Merck synthetic compounds. In this role, he was responsible for process definition and optimization, including the application of appropriate phenomenological and empirical models with the goal of gaining technical understanding of API chemical processes, and enabling a science and risk based approach to process development. During his 32-year career with Merck, John has led the API launch of nine products, operation of pilot plant facilities at Rahway, and the compliance function, encompassing safety, environmental, and GMP areas. With an in-depth knowledge of drug development and process and product economics, Dr. Lepore has been a lecturer at FDA staff training (ORA), and a guest lecturer at both the University of Michigan, and Rutgers University. He serves on the ISPE PQLI Technical Steering Committee, the task teams for ICH Q12 and Patient Centric Specifications, and was Chair of the Design Space Task Team. John received a Ph.D in Chemical and Biochemical Engineering at Rutgers University in New Brunswick, NJ, and a BS degree in Chemical Engineering from Worcester Polytechnic Institute.
