• Develop and optimize packaging solutions for drug/device combination products, considering factors such as product integrity, stability, regulatory compliance, and patient usability and safety. • Conduct packaging material selection and testing to ensure compatibility, protection, and adherence to regulatory standards. • Optimize packaging design for efficient manufacturing, labeling, storage, and transportation within the pharmaceutical industry. • Manage the shipping validation and transport qualification of temperature-controlled shipment of goods across the end-to-end supply chain. • Direct day-to-day project oversight, including projection of material requirements, budgets, and timelines. • Collaborate with cross-functional teams to address any vendor-related issues, including non-conformances, quality concerns, or supply disruptions. • Conduct risk assessments and develop contingency plans to mitigate potential packaging issues or regulatory challenges. • Manage technical oversight and guidance to CMOs for packaging development, optimization, process validation, and cGMP packaging of biologics drug product in support of clinical and commercial supply. • Manage the development of printed components artwork partnering with CMC, Regulatory, Marketing, Legal, CMOs and third-party printer/converters. • Execute plans in accordance with industry standards, cGMP, ICH, and FDA regulations. • Write, update and review relevant sections for regulatory submissions. • Prepare, review, or edit cGMP protocols, reports, CMC regulatory and quality documents