Overview In this role you drive mass spectrometry-based characterization of extractables and leachables for medical devices. You will own method development, validation, and troubleshooting across LC-MS, GC-MS, and ICP-MS within a center of excellence for analytical chemistry. You'll lead complex investigations, provide technical oversight, and guide cross-functional teams to ensure product quality and patient safety. This is a chance to shape analytical strategies in a high-stakes, global environment.
Responsibilities- Develop and validate analytical methods for extractables and leachables using HPLC-MS, GC-MS, and ICP-MS
- Perform mass spectrometry-based structural elucidation
- Support routine leachables/extractables analysis and EO/ECH residual testing on medical devices
- Lead method development, verification, validation, and transfer across multiple workstreams
- Provide technical authority for root-cause analysis of failures, OOS, deviations, and CAPA
- Define data interpretation approaches, trends, and reports; assess conformity and opinion statements
- Oversee equipment qualifications and software validation for complex analytical systems
- Lead standardization of lab practices and technical decision-making across programs
- Manage complex process improvement projects (BEST, 6S, Lean) and support safety/quality initiatives
- Mentor and guide junior staff; review results and ensure technical rigor
Key requirements- Bachelor's degree in Chemistry or equivalent with 8 years of related MS/unknowns analysis experience OR
- Master's degree in Chemistry or equivalent with 6 years of related experience OR
- Ph.D. in Chemistry or equivalent with 4 years of related experience
- Excellent communication and interpersonal skills
- Strong collaboration and cross-functional influence
- Problem-solving and analytical mindset
- Mass spectrometry-based unknowns analysis
- LC-MS, GC-MS, ICP-MS instrumentation
- HPLC-MS, HPLC-DAD, GC-MS/HS, TOC, FT-IR, UV
