John Lepore currently is a Sr. Director in Chemical Process Development and Commercialization, John leads API process development for Merck synthetic compounds. In this role, he is 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 API process development. In addition, he oversees manufacture of material used in clinical trials, and technical transfer of process knowledge to the Merck Supply Organization. During his 21 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 is a regular instructor for training of FDA staff (ORA), and a guest lecturer at both the University of Michigan (Pharmaceutical Engineering Program), and Rutgers University (Lerner Center for Pharmaceutical Management Studies). He serves on the ISPE PQLI Technical Steering Committee and is Chair of the Design Space Task Team. Dr. Lepore is also a member of the Development Technical Committee for the Product Quality Research Institute (PQRI). 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.