Karen Steffen is a senior CMC and Quality consultant with more than 25 years of experience helping biopharma companies advance complex products from development through commercialization. Her expertise spans GMP manufacturing, Quality, CDMO oversight, and CMC leadership, with contributions to the development and launch of ProvengeTM, TrodelvyTM, and OmidriaTM. Karen is known for bringing strategic guidance and practical execution to clients navigating critical development, quality, and manufacturing milestones. Most recently, Karen has served as Head of Quality for CAR-T and ADC programs and as the CMC Program Manager for cell therapy and small molecule programs. She holds a BS in Medical Microbiology & Immunology from the University of Wisconsin–Madison.