Associate Director, Technical Operations - Drug Product

Role: Associate Director of Technical Operations – Drug Product, overseeing manufacturing, scale-up, validation, and commercialization of a small molecule, solid oral drug product for rare diseases. Responsibilities: manage external CDMOs, oversee process development, validation, and tech transfer; review manufacturing documentation; support GMP quality systems; collaborate on CMC development, regulatory filings (INDs, NDAs); ensure compliance with US/EU GMP standards; provide technical guidance on process readiness and risk management. Requirements: Bachelor’s in Chemistry, Pharma Sciences, or related; 8+ years in small molecule drug product manufacturing with expertise in scale-up, late-phase development, and commercialization; experience with amorphous solid dispersions and solid oral products; proven history managing global CDMOs and regulatory submissions. Preferred: advanced degrees, Six Sigma skills, statistical knowledge. HighValue: Small molecule, solid oral drug products; amorphous dispersions; late-stage clinical and commercial phases; GMP compliance; global CDMO oversight; US and EU regulatory knowledge. WorkSetup: remote with 10-20% domestic and international travel.