Principal Chemist
Core
Lead analytical chemistry and mass spectrometry-based structural elucidation of extractables and leachables for medical devices to ensure product safety and quality.
Role type
Principal Chemist (Analytical Chemistry / Mass Spectrometry)
Builds
Analytical methods, validation protocols, and quality data for medical device extractables and leachables.
Domain
Medical Devices / Analytical Chemistry / Quality Assurance
Required skills
Mass spectrometry (LC-MS, GC-MS, ICP-MS), structural elucidation, method development and validation, root cause analysis, technical strategy, laboratory management, GMP/GLP knowledge, project management, mentoring
Preferred skills
Chemical principles and theories, laboratory equipment operation (GC, HPLC, TOC, FT-IR, AAS), regulatory guidance interpretation (ISO, GLP/GMP/QSIT), MS Office, Analytical Equipment Systems (ChemStation, MassHunter)
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; perform mass spec structural elucidation; own technical direction for complex laboratory methods and instrumentation; provide technical authority for root cause analysis of failures and OOS; establish and execute lifecycle management of methods and protocols; lead standardization of laboratory practices; mentor lower-level employees.
Seniority
Principal, hands-on IC with technical leadership
