Senior Manager/Associate Director, CMC, Analytical Development

Qualification

Ph.D. or M. Sc. in analytical chemistry or a closely-related field with 5+ (Senior Manager level) or 10+ (Associate Director level) years of directly-related industry experience. Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3). Extensive analytical method development, troubleshooting, and validation experience. In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods), the identification of impurities and degradation products, and reference standard qualification. Demonstrated knowledge of drug development, CDMO management, manufacturing, and regulatory CMC. Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to the testing of both drug substances and drug products in both development and commercial contexts. Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices. Experience preparing and updating regulatory filings (IND, IMPD, CTA, NDA, MAA). Ability to effectively organize and prioritize tasks to achieve established deadlines. Abil