James Blackwell, Ph.D.
Specialties: CMC, Process Development, Quality, Laboratories, Manufacturing
Biography
As Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC, Dr. Blackwell has been a leading consultant to the regulated life science industry 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 third party consent decree monitoring, quality system remediation, and organizational 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 has provided due diligence expertise for more than fifty products, technologies and companies.
James is a member of ISPE, PDA, AAPS and RAPS. He holds degrees in chemical engineering (Ph.D.), microbiology (M.S.), and business/technology management (M.B.A./M.S.).