John Lepore Email & Phone Number

My experience is focused on the development, commercialization and launch of small molecule assets, mostly in the area of active pharmaceutical ingredient processes with some drug product activities mixed in. In my most recent role as QbD and CMC Practices Lead, I have been involved with nearly every small molecule asset filed between 2014 and present, helping teams frame their science and risk based development efforts into a well prepared regulatory submission. Prior to that, serving in roles ranging from individual contributor to manager of managers, I led and/or supported development and commercialization of 14 marketed products, and led economic evaluation for internal and in-licensed assets. During my tenure as a pilot plant area head, and responsible for operations and compliance activities (safety/environmental/GMP), I drove the development of a rigorous development quality system which enabled product launch from pilot facilities on several occasions, and continues as the framework used today (with numerous improvements and updates to maintain the “c” in cGMP).I led the Quality by Design program at Merck, and transformed the organization to pursue science and risk based development, requiring training of over a thousand development personnel in the new framework at multiple sites, to realize an integrated science and risk based development model that extends from late development into manufacturing. Additionally, I am well-published and recognized broadly as a thought leader, having had significant regulatory advocacy experience, including supporting ICH activities through PhRMA and or EFPIA, along with leadership roles in relevant areas of AIChE, ISPE, and PQRI.Specialties: Small molecule development; process economics, recruiting, coaching, and mentoring,; crystallization; QbD; Technology Transfer; Process Validation; Product Launches; Quality Systems design and maintenance; Compliance; Regulatory Strategy; Risk Management.

Listed skills include R&D, Chemical Engineering, Technology Transfer, Commercialization, and 4 others.