Associate Director, Technical Operations - Drug Product

Role: Associate Director, Technical Operations – Drug Product, overseeing manufacturing, scale-up, validation, and commercialization of small molecule solid oral drug products for rare diseases. Responsibilities: manage external CDMOs for GMP production, process development, and validation; review and approve manufacturing documents; support quality systems, deviations, and regulatory filings (INDs, NDAs); collaborate on CMC development and ensure regulatory compliance. Requirements: Bachelor’s in Chemistry, Pharmaceutical Sciences, or related field; 8+ years in small molecule drug manufacturing with experience in scale-up, late-phase clinical development, and commercialization; expertise in process development, amorphous solid dispersions, and regulatory submissions; managing global CDMOs preferred. HighValue: small molecule solid oral drug development, GMP manufacturing, CMC documentation, regulatory filings, experience with amorphous dispersions, and late-stage clinical or commercial manufacturing. WorkSetup: remote with 10-20% domestic/international travel.