Research Scientist I
Core
Lead extractables and leachables studies, analytical method development, validation, and transfer to ensure safety and quality of medical products.
Role type
Senior IC analytical chemist (chemical characterization)
Builds
Life-saving medical products
Domain
Medical devices / Pharmaceutical
Required skills
LC-MS, GC-MS, UV, FID, wet chemistry, method validation, regulatory compliance (ICH/USP/cGxP), data interpretation, experimental design
Preferred skills
Chromeleon, Compound Discoverer, UNIFI, MassHunter, SCIEX Analyst, mentoring
Technologies
LC-MS, GC-MS, UV, FID, Chromeleon, Compound Discoverer, UNIFI, MassHunter, SCIEX Analyst
Responsibilities
Lead extractables and leachables studies; Conduct impurity investigations; Partner with Regulatory, Toxicology, and Quality teams; Drive investigations for out-of-specification results; Develop and maintain analytical procedures; Interpret industry regulations; Analyze complex data; Mentor colleagues
Seniority
Senior, hands-on IC
