James Blackwell Windshire Group

Dr. James Blackwell is one of the industries’ top experts in industry investigations. As Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC., Dr. Blackwell has been a leading consultant for almost two decades in the areas of CMC, process development, quality, laboratories, and manufacturing for all major therapeutic classes, from pre-IND through commercial operations. He has been involved with a consent decree and third-party monitoring, quality system remediation, and quality mentoring for several multinational corporations. Dr. Blackwell has held senior technical positions for leading companies and was head of site technical operations for the launch of Humira™. He has been on the founding management team of several start-ups. Dr. Blackwell’s accomplishments include working on some of the industry’s most innovative and important therapies and providing due diligence expertise for more than forty investment opportunities. James is a member of ISPE, PDA, AAPS, ISCT, and RAPS. He holds degrees in chemical engineering (Ph.D.), microbiology (M.S.), and dual business/technology management (M.B.A./M.S.).