For a contract research organization (Frontage Laboratories, Inc. – Exton, PA): perform method validation, development and transfer for drug products and substances; perform release and stability sample analyses; perform extractable and leachable studies; API and finished product release testing; commercial product stability testing and storage and GLP dosing sample analysis; draft pharmaceutical sample reports all under current Good Manufacturing Practices (cGMP), GLP and all applicable requirements.
- Master of Science or foreign equivalent degree in Pharmacy, Pharmaceutical Chemistry or a related field.
- 6 months experience in job offered or 6 months experience as an Analytical Chemist in regulated environment. This required experience must include 6 months experience in stability and release test, method development and validation for pharmaceutical products, analysis of zeta potential and particle size of Nano-emulsion, optimization of water soluble molecules, USP testing such as viscosity, loss on drying, residue on ignition, heavy metal, spectrophotometric identification, water determination and thin-layer chromatographic identification.
- Proficient with High Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultraviolet-Visible Spectroscopy (UV) and Fourier Transform Infra-red Spectroscopy (FTIR), Karl Fisher, LC-MS and HPLC-CAD.