James Blackwell

President and Principal Consultant at The Windshire Group, LLC

As Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC, Dr. Blackwell is a leading consultant to the regulated life science industry for CMC, process development, quality, laboratory, and manufacturing, spanning early process development through commercial operations. Windshire helps speeds development and commercialization for all major therapeutic classes, saving our clients time and money.

Dr. Blackwell has held senior technical positions and was head of site technical operations for the launch of Humira™ and has been on the founding management team of several start-ups. He has been involved with third party consent decree monitoring, quality system remediation, and organizational quality mentoring for several multinational corporations. Dr. Blackwell’s accomplishments include providing due diligence expertise for more than fifty projects.

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.).