Director, Pharmaceutical Development, Drug Product Manufacturing

Role: Senior technical leader responsible for outsourced drug product development and manufacturing within a late-stage biopharma focused on psychiatric and neurological therapeutics, including psychedelics. Objectives include overseeing formulation, process development, technology transfer, validation, lifecycle management, and commercial readiness. Responsibilities: serve as primary contact for CDMO oversight, lead formulation and process strategy, manage manufacturing investigations, deviations, CAPAs, and change controls; ensure regulatory compliance; lead secondary packaging development; support regulatory submissions and inspections; manage external partners and cross-functional teams; mentor junior staff. Requirements: Bachelor's in Pharmaceutical Sciences, Chemistry, or related; 12+ years in pharmaceutical drug product development, manufacturing science, or CMC; extensive experience with outsourced manufacturing, process validation, cGMP, and regulatory expectations for oral dosage products; proven leadership in virtual/outsourced settings, influencing external partners, and contributing to regulatory strategies. Preferred: experience with lifecycle management, regulatory submissions, statistical process monitoring, and mentoring. High-Value: biologics or small molecules targeting neuropsychiatric indications, late-stage/clinical development, process validation, and commercial manufacturing. Work setup and travel details are not specified.