Principal Chemist

Imagine how your ideas and expertise can change a patient's life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

This is an opportunity to join a state-of-the-art medical device chemical characterization laboratory and center of excellence for analytical chemistry and unknowns analysis. The Principal Chemist will specialize in mass spectrometry-based structural elucidation of extractables and leachables and the development, validation, optimization, and troubleshooting of analytical methods using liquid chromatography mass spectrometer (LC-MS and gas chromatography mass spectrometer (GC-MS), with inductively coupled mass spectrometer (ICP-MS) and related technologies supporting broader chemical characterization and complex investigations.

• Support the test method development, validation, and testing on Extractables and Leachables using high performance liquid chromatography mass spectrometer (HPLC-MS), GC-MS, and ICP-MS.
• Perform mass spec structural elucidation of extractables and leachables.
• Support routine analysis of leachables and extractables and EO/ECH residual on medical device.
• Assist in test method development and validation for a variety of cleaning validations using GC-MS, GC-MS/HS, HPLC-MS, HPLC-DAD, ICP-MS, TOC, FT-IR, UV, etc.
• Own technical direction for complex laboratory methods, instrumentation platforms, and investigation approaches across multiple work streams.
• Provide technical oversight for complex testing, data review, and qualification strategies for new or modified devices and/or processes.
• Provide technical authority for root cause analysis of product/sample failures and Out-of-Specifications (OOS), incidents, deviations and their significance, non-conformances, and CAPA; review technical conclusions, resolve escalated issues, and determine appropriate corrective and preventive actions.
• Establish technical expectations and execute development, modification, verification, validation, transfer, and lifecycle management of methods, lab-specific protocols, and reports in collaboration with intra- and inter-departmental teams.
• Define technical strategy for equipment qualifications and software validation activities for complex analytical systems and ensure alignment to laboratory and quality requirements.
• Establish expectations and perform interpretation of data and analysis of results, including statements of conformity or opinions and interpretations, trend analysis, and qualification strategies for new or modified devices and/or processes.
• Lead standardization of laboratory practices, technical decision-making, and review expectations across assigned methods, platforms, or programs.
• Lead complex process improvement projects (e.g., BEST, 6S, Lean), update procedures/forms, support safety and quality initiatives, and implement sustainable changes with management approval.
• Mentor and technically guide lower-level or new employees; report, review and authorize results; assess work techniques and provide feedback on procedures, methods, and technical rigor.

• Bachelor's Degree in Chemistry or equivalent with 8 years of previous related experience with unknowns analysis using mass spectrometry…