Executive Director, Process Development & CMC Lead

Role: Lead Process Development & CMC for biopharmaceutical pipeline, focusing on complex inhaled and particle-engineered products across late-stage development, including Phase 3, regulatory submissions, and commercial launch. Responsibilities: provide strategic technical leadership for process scale-up, characterization, transfer, and manufacturing readiness; serve as CMC Lead, chair cross-functional teams, develop phase-appropriate strategies, and ensure regulatory compliance; oversee technology transfer, GMP partnership, resource management, and team leadership; identify, assess, and mitigate technical and operational risks. Qualifications: PhD in relevant engineering or sciences with 18+ years (or MS/BS with 20+ years) pharmaceutical development experience; extensive leadership in Process Development, Manufacturing Science, and CMC functions; proven experience with late-phase development, regulatory filings, process validation, and commercial readiness; strong understanding of drug product and regulatory interdependencies; experience with inhaled products preferred. HighValue: late-stage development (Phase 3), inhaled or complex drug-device products, regulatory submissions (NDA/MAA), process validation, PPQ, and commercialization. WorkSetup: onsite in Danbury, CT (Monday-Thursday), remote Fridays; requires flexibility for cross-functional collaboration.