Principal Chemist
Core
Lead analytical chemistry and unknowns analysis for medical device extractables and leachables using mass spectrometry to ensure product safety and quality.
Role type
Principal Chemist (Analytical Chemistry)
Builds
Medical device extractables and leachables data, validated analytical methods, and quality assurance protocols.
Domain
Medical Devices / Analytical Chemistry
Required skills
Mass spectrometry (MS) structural elucidation, LC-MS/GC-MS/ICP-MS method development and validation, unknowns analysis, root cause analysis for OOS, technical strategy for equipment qualification, laboratory standardization, process improvement (Lean/6S), mentoring.
Preferred skills
Chemical principles and theories, laboratory equipment operation (GC, HPLC, TOC, FT-IR, AAS), regulatory guidance interpretation (ISO, GLP/GMP/QSIT), GMP documentation practices, project management, analytical software proficiency.
Technologies
LC-MS, GC-MS, ICP-MS, HPLC-DAD, TOC, FT-IR, UV, ChemStation, MassHunter
Responsibilities
Support test method development and validation for extractables/leachables/cleaning; perform mass spec structural elucidation; own technical direction for complex methods and investigations; provide technical authority for root cause analysis of failures/OOS; establish and execute lifecycle management of methods and protocols; define technical strategy for equipment/software qualification; lead standardization of lab practices and process improvement projects; mentor junior staff.
Seniority
Principal, hands-on IC with technical leadership