James Blackwell, Ph.D. M.B.A.
Head, Manufacturing (CMC)
Dr. James Blackwell is a greatly accomplished clinical research scientist and executive who has served as President and Principal Consultant, Manager and scientist at many biotech and pharmaceuticals companies including The Windshire Group, Abbott Laboratories, Sanofi Genzyme, Repligen, BioProcess Technology Consultants, Inc. among others. He has long and impressive experience encompassing early process development to commercial operations for development, manufacturing, quality, regulatory, operations, and commercialization. His product experience includes all major therapeutic classes and sub-classes with clients including 1) Stabilityshire service for stability data analysis, reporting, and management; 2) Continued process verification for process and quality monitoring, trending, reporting, and data analysis, 3) RegDocs365 and ARCC (audit ready compliant cloud) quality systems; 4) Learningshire for learning solutions, 5) Assurashire for augmented, virtual quality and technical support through RegDocs365 and ARCC or on site presence.
Dr. Blackwell completed his B.S.Ch.E. and MS education at Ohio State University, M.B.A./M.S. at University of Maryland University College, and his PhD in Chemical Engineering at Northeastern University.