R&D/Mfg Scientist II
Core
Performs routine and moderately sophisticated analytical testing on pharmaceutical raw materials and finished products to support process development and manufacturing operations.
Role type
Mid-level analytical scientist (pharmaceuticals)
Builds
Analytical data and validated test methods for drug substances and products
Domain
Pharmaceuticals / Analytical Chemistry
Required skills
HPLC, GC, Dissolution testing, cGMP compliance, method validation, Empower software, regulatory guidelines (ICH/USP/EP), data integrity
Preferred skills
FT-IR, UV, Karl Fischer Titration, IEF, ELISA, CGE, Dot-Blot, method development, project prioritization
Technologies
HPLC, GC, IEF, CGE, Empower, FT-IR, UV, Karl Fischer Titration
Responsibilities
Execute testing for strength, impurities, identity, potency, and dissolution; Lead/Execute development and validation of test methods; Perform daily instrument calibrations; Review cGMP analytical data; Author OOS investigations and technical reports; Communicate project status to management
Seniority
Mid-level, hands-on IC
