Jeffrey C. Baker, PhD National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

Dr. Jeffrey Baker is a cell physiologist and biochemist by training. He spent over 20 years in the pharmaceutical industry leading process development and manufacturing of both legacy and first in class biological products and then 10 years at the United States FDA as Deputy Director, Office of Biotechnology Products, CDER. In the latter role he received several CDER awards for renewing and rebalancing OBP review, inspection, and research practices and in 2018 received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology. products through sustained creative leadership and collaboration.” He was CDER liaison to Manufacturing USA and the Advanced Manufacturing National Program Office and worked on interagency advanced manufacturing program development during the COVID pandemic. He retired from the FDA in 2021 but remains active in the biotech community as a Senior Fellow in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Senior Strategic Advisor for the Center for Biotech Innovation at MIT, and as adjunct faculty/guest lecturer at several universities .