Accelerating Process Development:  New
Approaches to Biopharmaceutical Design

Dr. Blackwell has over 18 years experience in manufacturing, biopharmaceutical development and manufacturing, technical operations, and CMC regulatory issues. As a consultant, he has assisted many organizations with their CMC requirements, including IND and BLA filings. He has been involved with the commercialization of several of the world’s leading biopharmaceuticals and has held senior management and technical positions with Abbott Bioresearch Center, Genzyme, and Repligen Corporations. While at the Abbott Bioresearch Center, Dr. Blackwell oversaw site technical support for HUMIRA® arthritis drug production and served on the site validation review board and quality management teams. He also served on the project team for Abbott’s re-organization of its global pharmaceutical operations. At Genzyme, Dr. Blackwell provided technical support for several prominent commercial and clinical projects. He has also been a research scientist in cell culture and fermentation process development at Genzyme and Repligen.

Dr. Blackwell is Past President of the Greater Boston Chapter of ISPE and led ISPE’s Process and Product Development Community of Practice for several years at the society’s international level. He serves on the editorial review boards and is a reviewer for several prominent industry journals. Dr. Blackwell ha a MS degree in Microbiology; a Doctorate in Chemical Engineering and dual Master’s degrees in Business Administration and Technology Management.