Senior Scientist, Analytical Research & Development
Core
Developing, validating, and executing test methods for Drug Substances and Drug Products in a softgel manufacturing facility.
Role type
Senior Scientist, Analytical R&D (Physical/Clinical work)
Builds
Analytical methods, test results, and compliance documentation for pharmaceutical products.
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
physical/clinical work
Required skills
Method development and validation, HPLC/UPLC/GC/MS, wet chemistry (titrations, extractions), regulatory compliance (ICH/USP/EP), data acquisition systems (Chemstation/Empower/Totalchrom), SOP writing, hazardous waste handling
Preferred skills
Peptide handling and method development
Technologies
Chemstation, Empower, Totalchrom, HPLC, UPLC, GC, MS
Responsibilities
Independently develop and validate instrumental methods; Analyze finished products, in-process materials, and raw materials; Prepare reagents, standards, and media; Write and review analytical methods, deviations, protocols, SOPs; Lead analytical method transfer activities; Safely handle potent and teratogenic compounds
Seniority
Senior, hands-on IC