Research Scientist I
Core
Lead extractables & leachables studies and perform advanced chemical/impurity analyses to support product development and compliance in healthcare.
Role type
Senior IC analytical chemist (extractables & leachables)
Builds
Analytical methods, validation reports, and compliant data for medical devices
Domain
Healthcare / Analytical Chemistry
Required skills
analytical method development, validation, transfer, wet chemistry, GC/MS, LC/MS, root cause analysis, regulatory compliance (ICH/USP/cGxP), data interpretation
Preferred skills
MassHunter, Empower, Chromeleon, e-Noval, mentoring, continuous improvement
Technologies
LC, GC, ICP, MS, MassHunter, Empower, Chromeleon, e-Noval
Responsibilities
Lead extractables & leachables studies; Perform advanced chemical and impurity analyses; Investigate OOS/OOT results; Author and maintain analytical protocols and validation reports; Partner with Regulatory, Toxicology, Quality, and Manufacturing teams; Drive continuous improvement initiatives
Seniority
Mid-Senior, hands-on IC