Jim Monsor - Director, LifeSciTN Statewide Mentor Network
Jim served as the head of operations for BioMimetic Therapeutics for more than 13 years. He built and led the entire scope of operations and quality functions, and led the Life Sciences Center Construction Project. He is the fourth employee and was instrumental in leading BMTI through critical growth to a 100 person operation. He led multiple product development and commercialization teams and was a core leader in completing clinical development and trial execution; manufacturing process development and qualification; filing development, submission, and approval in less than four years for a combination PMA product with a team of less than ten people. Previously, Jim spent fifteen years at Abbott Laboratories, and more recently was Director of Product Supply for ALK-Abello, where he was responsible for the entire product supply chain for US operations. He has very broad experience in supply chain management, quality, regulatory, commercial operations, IT, and facilities management for drug, device, biologics, combination products as well as bulk drug products. His experience spans early stage research through all phases of development, product launches, and routine commercial operations in US and international markets.