The Senior Scientist, Analytical Method Development & Validation is responsible for developing, validating, transferring, troubleshooting, and maintaining analytical methods for drug substances, drug products, raw materials, stability samples, and related pharmaceutical materials.
Competitive Salary: $100,000-$125,000 (based on experience)
- Ensure strict adherence to cGMP, GLP, GCP, cGxP, data integrity requirements, and company policies
- Maintain compliance with FDA, ICH, USP, EP, and other applicable regulatory requirements
- Develop analytical methods for assay, related substances, dissolution, residual solvents, elemental impurities, preservative content, extractable/leachable studies
- Optimize chromatographic and spectroscopic techniques including HPLC, UPLC, GC, ICP-MS, UV-Visible, FTIR, TOC
- Perform forced degradation and method optimization studies
- Ph.D.
- M.S.
- B.S.
- Nice to have: Waters Empower
- Nice to have: Headspace GC
- Medical
- dental
- vision
- Paid time off
- annual bonus