Dr. Jeffrey C. Baker received his doctorate in biochemistry from the University of North Texas and completed post-doctoral studies at the University of California, Berkeley before joining the biosynthetic process development group at Eli Lilly & Co. While at Lilly, Dr. Baker led the development of several commercial bioproducts from bench top purification to global launch. Moving to Lilly’s Manufacturing Sciences and Technology component, he formed and led the Global Validation Practices Team. After completing his certification as a Lean Six Sigma Black Belt, Dr. Baker led several initiatives related to assessment of control and capability and functional governance processes. Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at MedImmune where he was engaged in both organizational redesign and plant start up activities. Dr. Baker was recently appointed Deputy Director of the Office of Biotechnology, CDER at the United States Food and Drug Administration.