Dr. Courtney’s experience extends from R&D to analytical method development, validation, implementation, method transfer, and optimization of test methods for the cGMP setting per USP and ICH guidelines. She is the General Manager for Element Ann Arbor, an analytical lab in our Life Sciences business. She is a CMC professional in the Biological therapeutic space, and specializes in applying analytical strategies to meet regulatory intent.
Dr. Courtney has over 15 years of experience focusing on large molecule pharmaceuticals and CMC. Her technical background provides the foundation for effective authorship of INDs, BLAs and MAAs for biological therapeutic molecules, as well as responses to requests and questions from the FDA, EMA, and PMDA.
Prior to her current role as General Manager, Dr. Courtney was the Director of Biologics at Element's facility in Ann Arbor, Michigan. She holds a Ph.D. in biochemistry from the University of Wisconsin-Madison.
