Associate Director, Drug Product Development

Role: Associate Director, Drug Product Development overseeing outsourced manufacturing and formulation activities for early and late-phase psychiatric and neurological therapeutics, including psychedelics like LSD and R-enantiomer of MDMA. Responsibilities: serve as technical lead and primary contact for CDMOs supporting drug product manufacturing, process development, tech transfer, validation, and scale-up; oversee process validation strategies, batch record review, and troubleshooting; lead secondary packaging development for late-stage products; ensure alignment with regulatory and quality expectations; monitor manufacturing performance for continuous improvement. Requirements: degree in Pharmaceutical Sciences, Chemistry, Chemical or Biomedical Engineering; 10+ years in pharmaceutical drug product development, manufacturing science, or CMC functions; experience managing CDMOs in virtual environments; strong knowledge of cGMP for OSD, process development, validation, and risk-based approaches; ability to influence external manufacturing partners. Preferred: experience with regulatory submissions, lifecycle management, post-approval changes, statistical data analysis, and working in highly outsourced biotech settings. High-Value: expertise in small molecule/psychedelic drug development, process validation, CMC regulatory submissions, and virtual manufacturing oversight. WorkSetup: not specified; salary range $150K-$202K plus benefits.