Delivery Partner, CMC & Manufacturing Services, Converge Consulting
Dr. James Blackwell is a leading life science consultant with broad CMC and manufacturing experience spanning early process development through commercial operations. James brings extensive product experience with antibodies, vaccines, recombinant proteins, small molecules, peptides, cell therapy, and medical devices to clients ranging from virtual startups to leading multinational companies. His regulatory experience includes INDs, PAIs, DMFs, and leading NDA CMC submissions. James also has extensive experience evaluating and selecting CMOs, as well as providing oversight and management of external operations. He has been involved with 3rd party consent decree monitoring, quality system remediation, and organizational mentoring.
James was on the formative management team and led manufacturing and technical operations for Shore Therapeutics’ successful recommercialization of Fenoglide. His accomplishments include providing due diligence support for over 40 product, company, and technology strategic initiatives that have involved product analysis and CMC risk assessments for investors, facility and site operations assessment, and evaluation of both new business opportunities and novel product or process technologies. James 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 MBA/MS in Business/Technology Management from the University of Maryland.