Dr. James Blackwell is the Practice Lead for CMC and Manufacturing Technical Services at Converge Consulting, delivering best-in-class services in process and product development, analytical development, formulation, manufacturing and technical operations. He brings extensive CMC and manufacturing experience that spans early process development through commercial operations, and product types including antibodies, vaccines, recombinant proteins, small molecules, peptides, cell therapy and medical devices.
In his work with clients, Dr. Blackwell has provided due diligence for over 40 product, company, and technology strategic initiatives, involving 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.
Dr. Blackwell has extensive experience evaluating and selecting CMOs, as well as providing oversight and management of external operations. He 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.
Dr. Blackwell served on Shore Therapeutics’ formative management team and led manufacturing and technical operations during Fenoglide’s successful recommercialization.
Dr. Blackwell 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.