Associate Director, Chemical Development

Role: Associate Director, Chemical Development, overseeing cGMP manufacturing and process development for drug substance from preclinical to commercial stages. Responsibilities: manage RSMs and DS manufacturing, scale-up, process optimization, process characterization, validation, and regulatory submission support; lead CMO oversight, process validation, and DS supply chain management; ensure compliance with cGMP, ICH, FDA, and EU standards; prepare regulatory documents and technical reports; represent company before regulatory agencies. Requirements: PhD in Chemical Engineering, Pharmaceutical Chemistry, or related field; 5+ years in pharmaceutical/biotech CMC/cGMP environment; experience in synthesis route development, oversight of CMOs, IND/NDA module authoring, and adherence to ICH Q7 and GMP guidelines. High-Value: cGMP manufacturing, process development, regulatory submissions (IND/IMPD, NDA/MAA), process validation, scale-up, pharmaceutical chemistry. WorkSetup: based in Brisbane, CA; up to 50% domestic and international travel.