FSP - Scientist - Analytical Development Reference Standard
Core
Develop, qualify, and manage compendial and internal reference standards for small-molecule programs, executing analytical method development and validation to support identity, purity, potency, and stability assessments.
Role type
Analytical Development Scientist (Reference Standards)
Builds
Reference standards, working standards, and analytical methods for drug substances and products
Domain
Pharmaceutical small-molecule development
Required skills
HPLC analysis and troubleshooting, chromatography, spectroscopy, GMP compliance, regulatory submission support (IND/IMPD/NDA/BLA), stability study execution, instrumental method development (HPLC, GC, TGA, DSC, MS, FTIR), data evaluation, vendor coordination
Preferred skills
Masters degree, cross-functional collaboration, process improvement ideas
Technologies
HPLC, GC, TGA, DSC, MS, FTIR, MS-Excel, MS-Word, data systems for computer-controlled instrumentation
Responsibilities
Develop and qualify analytical methods for reference standards; perform analytical testing using instrumental techniques; evaluate data and investigate atypical results; collaborate with CMC and Quality Control; maintain laboratory records and inventory; coordinate instrument maintenance and vendor service calls.
Seniority
Mid-level Scientist (2+ years experience or Master's degree)