Associate Director Packaging Development

Role: Associate Director, Packaging Development, providing technical leadership for combination product packaging strategies from development through commercialization. Responsibilities: lead packaging programs for biologics, oral solids, and combination products; define and improve packaging processes, governance, and operating frameworks; collaborate cross-functionally with Device Engineering, Quality, Regulatory, Human Factors; author technical documents and support regulatory submissions; mentor engineers and identify continuous improvement opportunities. Requirements: B.S. in engineering or related fields; 10+ years industry experience in packaging, preferably in cGMP environments; strong expertise in packaging development, qualification, and commercialization; experience with biologics, cold chain logistics, and regulatory standards (FDA, EU MDR, ISO 11607/14971). Preferred: prior experience leading NDA/BLA submissions, working with CMOs, and supporting biologics or cold chain packaging. High-Value: biologics, combination products, NDA/BLA, cold chain, package qualification, cross-functional collaboration, governance and operating models. Work Setup: on-site Foster City, California; travel up to 20%.