• Responsible for leading and directing the design, development and manufacture of the combination products, specifically the drug delivery devices.
• Direct and lead oversight and interaction with the contract suppliers during the development, manufacturing, filling and packaging of the drug/device combination.
• Work closely with global supply chain process for both development programs (clinical supplies) and commercial products.
• Responsible for the pharmaceutical drug product/device combination, the manufacturing and control (CMC) section of regulatory and quality documents relating to the manufacture and filling of the combination product devices.
• Manage the design ...