Associate Director, Manufacturing Package Design

Role: Associate Director, Manufacturing Package Design, leading the technical strategy for primary and secondary packaging of late-stage clinical and commercial small molecule solid oral dosage forms. Responsibilities: oversee design, development, and validation of packaging systems; manage relationships with CMOs/CPOs; ensure packaging aligns with cGMP, quality, and regulatory standards; lead technology transfer, risk assessments, and change controls; collaborate across Manufacturing, Quality, Regulatory, and Supply Chain functions; support regulatory submissions and audits; mentor packaging teams; and drive continuous improvement initiatives. Requirements: Bachelor’s degree in engineering, materials science, chemistry, or related field; 7+ years’ sponsor-side experience in packaging design, supporting late-stage clinical or commercial programs; strong knowledge of cGMP, pharmaceutical packaging, and regulatory requirements; proven leadership in packaging strategies and vendor management. Preferred: experience with combination products, device packaging, and regulatory documentation. HighValue: focus on solid oral dosage, late-stage development, commercial readiness, and global supply chain integration. WorkSetup: based in the US with 10-20% domestic travel.