Research Associate I, R&D Charact
Core
Develop, validate, and transfer analytical methods for quantitative determination of nitrosamine impurities and leachables in pharmaceutical products using LC-MS and GC-MS.
Role type
Senior IC analytical chemist (nitrosamine characterization)
Builds
Validated analytical methods and data for new and existing pharmaceutical products
Domain
Pharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mass spectrometry (LC-MS, GC-MS, MS/MS), organic chemistry, chromatography, method development and validation, experimental design, data interpretation, regulatory compliance (GxP)
Preferred skills
nitrosamine study design, extractables and leachables (E&L) testing, trace organic analysis, environmental chemistry testing, NMR, IR, cGXP experience
Technologies
LC-MS, GC-MS, MS/MS, NMR, IR
Responsibilities
Develop and validate methods for nitrosamine impurities; design experiments to identify root causes of impurity formation; perform chemical extractions of container closure systems; interpret analytical data and identify trends; maintain knowledge of Quality System Regulations and GxP; share research outcomes with the team
Seniority
Senior, hands-on IC
