Denise Krawitz, PhD is Principal Consultant at CMC Paradigms LLC. Dr. Krawitz has 20 years of experience in chemistry, manufacturing and controls (CMC) biologics development and manufacturing, with an emphasis in analytical development and impurity analysis. Prior to becoming a consultant, Dr. Krawitz held positions of increasing responsibility at Genentech, BioMarin, and Ambrx. At Genentech, she led all research and developed strategies related to host cell proteins (HCPs). Dr. Krawitz has authored several peer-reviewed publications in the HCP field, has been invited to give presentations at multiple international conferences and serves on the Board at BEBPA (BioPharmaceutical Emerging Best Practices Association). She received her PhD in Molecular and Cell Biology from the University of California, Berkeley. Additionally, Dr. Krawitz received a Fulbright fellowship to study protein folding in Regensburg, Germany.