Kristen Nickens

Kristen Nickens is a Global CMC Regulatory Lead at Amgen, where she provides strategic oversight and leadership across Chemistry, Manufacturing, and Controls (CMC) regulatory activities for biologics and small molecules. Before joining Amgen, Kristen spent more than a decade at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), where she served as a Product Quality Team Lead in the Office of Pharmaceutical Quality (OPQ). There, she led interdisciplinary assessment teams to ensure compliance with quality standards for biologics and biosimilars. Earlier in her career, she held roles as a Product Quality Assessor within OPQ and as an Interagency Oncology Task Force Fellow in the Center for Biologics Evaluation and Research (CBER). She holds a Ph.D. in Molecular Medicine from The George Washington University in Washington, DC, and a B.S. in Biology from Johnson C. Smith University in Charlotte, NC.