Associate Scientist II / Scientist I, Analytical Validation Team
Core
Design and execute analytical method validation to generate precise, reliable, and reproducible data for early-phase development of New Chemical Entities (NCEs) drug substance and drug product.
Role type
Associate Scientist II, Analytical Validation
Builds
Analytical methods and validation data for preclinical and clinical programs
Domain
Pharmaceutical CMC (Chemistry, Manufacturing, and Controls)
Required skills
Analytical method validation, quantitative analysis, instrumental analysis, chromatography, spectroscopy, data interpretation, experimental design, GxP compliance, troubleshooting instrumentation, scientific literature review
Preferred skills
Theoretical and practical knowledge in chromatography and/or spectroscopy
Technologies
Electronic data acquisition and management systems
Responsibilities
Independently plan and perform routine analytical tasks, document experimental activities in a GMP compliant fashion, analyze and critique results noting deviations, troubleshoot experiments and instrumentation, apply new experimental techniques to project requirements, place data in proper scientific context by consulting literature
Seniority
Mid-level IC (3+ years experience with Bachelor's or Master's)
