Over 30 years experience in biotechnology Research and Development with a broad background in discovery and development of antibody and protein therapeutics in multiple therapeutic areas including cancer, metabolic diseases (NASH, Diabetes, Obesity, Age-Related Macular Degeneration), Fibrosis and Anti-Infectives. • Managed CMC development and outsourced cGMP manufacturing with multiple CMOs, CROs and internal teams from CMC, Quality, non-clinical development, bioanalytical assay development, clinical development, finance, contracts and business development to enter 11 candidates into the clinic. • Extensive experience in drug discovery and CMC development, engineering of antibodies and protein therapeutics, and advancement of drug candidates to non-clinical and clinical development, drug substance, drug product, fill/finish, labeling/packaging and multiple regulatory IND and IMPD filings.• Built multi-functional teams of up to 25 Scientists responsible for expression vector design, protein engineering, microbial cell production, mammalian cell production, protein purification and characterization and generation, selection and GMP development of monoclonal antibodies as therapeutic or reagent antibodies for multiple clinical candidates including: CRB-701 (anti Nectin-4 mAb-auristatin drug conjugate), CRB-601 (anti integrin Alpha5Beta8 mAb), TLY012 (engineered TRAIL), NGM282 (engineered human FGF19), NGM313 (anti-FGFR1c receptor agonistic mAb), NGM386 (engineered GDF15), NGM395 (long acting engineered GDF15), NGM120 (anti GFRAL mAb), NGM217 (mAb), NGM621 (anti compliment C3), PSMA ADC (anti-PSMA mAb-auristatin drug conjugate) and antitoxin mAbs for Clostridium difficile.