Jeffrey Baker

Independent Consultant

Dr. Baker received a bachelor’s degree in biochemistry and molecular biology at Northwestern University, doctorate in biochemistry from the University of North Texas and completed post-doctoral studies at the University of California, Berkeley. He joined Eli Lilly & Co in 1988 and led the development of several first in class biologics from bench top purification to global launch, supported post-launch manufacturing process development activities, and established and led Lilly’s Global Validation Practices Team. Dr. Baker received the Lilly President’s Award twice, once for work associated with the development and launch of Humalog, the first insulin analog and once of work associated with the development and launch of drotecogen alfa, the first protein therapeutic manufactured in human cells. After completing his certification as a Lean Six Sigma Black Belt, Dr. Baker led corporate initiatives related to control, capability, and functional governance in pharmaceutical manufacturing. Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at MedImmune, a subsidiary of AstraZeneca and, in 2011, Dr. Baker was appointed Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research at the FDA. Dr. Baker helped establish the Quality Management System used today in OBP and has been recognized with several CDER citations for leadership and program development. He was a member of the team which conceptualized and stood up the Office of Pharmaceutical Quality and has participated in the development of regulatory guidances and operational policies for CDER and reporting offices. In 2018, Dr. Baker received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.” He is currently FDA liaison to the Advanced Manufacturing National Program Office at NIST where he engages with biopharmaceutical manufacturing stakeholders to advance the National Strategic Plan for Manufacturing in the United States.