Manager, Drug Product, Packaging

Role: Lead packaging technical operations for commercial-stage oncology products, overseeing transfer, qualification, validation, lifecycle management, and continuous improvement at external CMOs. Responsibilities: manage packaging performance, assess and ensure site capability, lead technical transfers, qualification, validation, and post-approval changes; address deviations and quality issues; collaborate with Quality, Supply Chain, Regulatory, and Manufacturing teams to ensure cGMP compliance and inspection readiness. Requirements: Bachelor’s or Master’s in Packaging Engineering, Packaging Science, or related field; 6–8 years of experience in pharmaceutical, biotech, or regulated industries; demonstrated expertise with packaging systems, equipment, validation, and quality systems; experience managing external CMOs and supporting regulatory audits. Preferred: strong project management, cross-functional collaboration, technical writing, and travel readiness. High-Value: focus on commercial biologics or small molecules in oncology, lifecycle management, validation and qualification expertise, cGMP compliance, and external partner oversight. Work setup: onsite at Redwood City, CA, with travel as needed.