Dr. James Blackwell is the Practice Lead for CMC and Manufacturing Technical Services at Converge Consulting. He delivers best-in-class services in process and product development, analytical development, formulation, manufacturing and technical operations. Blackwell brings extensive CMC and manufacturing experience that spans early process development through commercial operations. He also works with many product types including antibodies, vaccines, recombinant proteins, small molecules, peptides, cell therapy and medical devices.
Blackwell has provided due diligence for over 40 product, company, and technology strategic initiatives. These involved product analysis and CMC risk assessments for investors, facility and site operations assessments. He has also conducted evaluations of new business opportunities and novel product or process technologies.
He has extensive experience evaluating and selecting CMOs, as well as providing oversight and management of external operations. Blackwell has been involved with third party consent decree monitoring, quality system remediation, and organizational mentoring. His regulatory experience includes INDs, PAIs, DMFs, and leading NDA CMC submissions.
Blackwell served on Shore Therapeutics’ formative management team and led manufacturing and technical operations during Fenoglide’s successful recommercialization.
He is a member of ISPE, PDA, AAPS and RAPS.
He holds a PhD in Chemical Engineering from Northeastern University, a MS in Microbiology from the Ohio State University, and a MS/MBA in Business and Technology Management from the University of Maryland.