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About Dr. James Blackwell – Dr. James Blackwell is The Founder, President and Principal Consultant of The Windshire Group. Dr. Blackwell has been a prominent industry consultant for over twelve years, working on a wide variety of CMC and quality issues for a broad range of companies, investors, and product types at all stages of the product life cycle. Prior to consulting, he held several senior positions in technical operations, manufacturing and process development at prominent operating companies. See his latest presentations and publications on LinkedIn.

Thought Leadership

Dr. Blackwell has been a leader and active in industry professional organizations (ISPE, AAPS, PDA, RAPS), is a frequent invited speaker. His most recent publication is a landmark paper, Proof of Concept for a Banding Scheme to Support Risk Assessments Related to Multi-Product Biologics Manufacturing.

All of our consultants are prominent industry subject matter experts thought leaders in their fields.