Scientist with in-depth R&D experience in pharmaceutical industry, focused on medicinal/synthetic organic and analytical chemistry, API manufacturing, FDA submissions. Knowledge of cancer and antibiotic drug discovery and development fields. Leader of multidisciplinary teams conducting R&D projects resulting in new chemical entities entering clinical trials. Compiling IND sections for submission to FDA. Management of multiple external programs at CROs and CRLs.Professional Competence:• CMC manufacturing for GMP API and Drug Substance• Management of CROs, CMOs, CRLs• Analytical Method Development and QC• Project/Staff Management• Regulatory Filings for INDs• Drug Discovery and Development• Medicinal/Synthetic Organic Chemistry
Listed skills include Drug Discovery, Medicinal Chemistry, Chemistry, Organic Chemistry, and 6 others.