Dr. Denise Krawitz

Dr. Krawitz, Principal Consultant at CMC Paradigms LLC, is based out of the San Francisco Bay Area.  With over 15 years of strategic and technical CMC development experience, Denise provides consulting expertise to large and small biotechnology companies to move products from late-stage research to commercialization efficiently. Denise’s skill set is the product of working directly as a bench scientist, group, leader, project team leader, and project manager.  She has broad process development experience, with an emphasis in analytical development and impurity analysis.

Prior to becoming a consultant, Denise served multiple technical and team leadership roles at Genentech, BioMarin, and Ambrx.  At Genentech, she was the subject matter expert for host cell protein (HCP) strategy and testing.  Denise led all R&D related to HCP strategy, including development of HCP ELISAs, characterization of HCP ELISA reagents, CHO and E. coli proteomics, and implementation of orthogonal techniques to monitor HCPs.  Additionally, Denise was responsible for setting the strategic direction for HCP management across the Genentech pipeline, including setting acceptance criteria, risk assessments, and authoring all regulatory documents.  Denise has authored several peer-reviewed publications in the HCP field, and been invited to give presentations at multiple international conferences.

Denise received her Doctor of Philosophy in Molecular and Cell Biology from the University of California, Berkeley.  Her focus was establishment of chromatin structures that modulate gene expression.  Additionally, she received a Fulbright fellowship to study protein folding in Regensburg, Germany.