The AbbVie Device & Combination Product Development (DCPD) team provides expertise to enable the development of drug delivery systems for use with AbbVie therapeutic products as well as bespoke medical device development to support AbbVie’s eye care and aesthetics portfolios. In this role, you will be leading programs in development of robust drug delivery systems at the intersection of engineering and biopharmaceutics, as well as improving capabilities within our state-of-the-art laboratories. You will be working with a global team of exceptional scientists, engineers, and leaders on a variety of drug delivery systems from autoinjectors to advanced electromechanical infusion pump systems. Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use. You will independently conceive, execute, and communicate novel multi-disciplinary development strategies that achieve project and area goals.

We are looking for an individual with a comprehensive knowledge of development of medical devices and drug delivery systems to support AbbVie’s therapeutic pipeline.

Responsibilities:

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• Define verification strategy and lead planning and execution of the activities to meet program objectives. Create verification plans, protocols, records, and reports. Determine sample size strategy based on strong scientific rationale conforming to internal and regulatory guidelines.
• Lead verification activities within cross-functional teams.
• Lead execution of test procedures and writing of protocols supporting engineering testing and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Experience using Zwick and flow measurement equipment is preferred. Familiarity with 3D printing, CT Scanners, Viscometers, Climate Chambers, etc. is a plus.
• Lead root cause investigations and issue resolutions.
• Define, develop, and validate test methods.
• Implement new testing approaches for state-of-the-art testing & verification.
• Drive global harmonization of development & verification processes.