Associate Director, CMC Analytical

Coordinate and oversee analytical development and commercial testing at contract testing laboratories for drug substance, drug product, and stability programs. Manage quality records, support regulatory filings, and provide technical leadership for operational procedures. Oversee analytical activities at CMO and CTL laboratories, including method development, validation, release, and stability. Perform data review, external auditing, exceptions management, and change control for GMP quality testing. Ensure contracted third-party testing complies with quality practices. Provide analytical development support for drug substance and formulation development. Support commercial manufacturing activities. Lead analytical method development, validation, and transfer activities. Lead the development and management of stage-appropriate stability programs. Lead the establishment and justification of specifications for drug substances and drug products. Author technical sections in regulatory submissions and respond to regulatory questions. Contribute to Annual Product Reviews. Support operational budgets, cost controls, and resource planning. Serve as an SME for analytical methodologies, specifications, stability, and reference standards during inspections and audits. Support inspection readiness activities.