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.