Associate Director, Manufacturing Package Design

Role: Associate Director, Manufacturing Package Design, leading the technical strategy and design of primary and secondary packaging for late-stage clinical and commercial small molecule solid oral dosage forms. Responsibilities include managing design development, qualification, technology transfer, and ensuring packaging solutions meet quality, regulatory, and manufacturing readiness standards. The role involves collaboration with Manufacturing, Quality, Regulatory, Supply Chain, and external CMOs/CPOs, overseeing packaging validation, change controls, and continuous improvement initiatives. Qualifications: Bachelor's in engineering, materials science, chemistry, or related field; 8–10 years of experience in sponsor-side packaging design supporting late-stage clinical and commercial programs, with strong knowledge of cGMP and pharmaceutical packaging standards. Preferred: advanced degree, experience authoring regulatory submissions, and expertise in combination product packaging. High-value specifics: focus on solid oral dosage packaging, technology transfer to commercial manufacturing, and international travel (~10–20%). The position is based in the US, full-time, exempt status, reporting to the Vice President, CMC.