Scientist (CMC) for Frontage Laboratories, Inc. - Exton, PA.
Provide high-quality analytical testing of finished products, raw materials, Active Pharmaceutical Ingredient (API), in-process products and stability samples; provide analytical method development, validation and verifications in Good Manufacturing Practice (GMP) environment; perform analysis of innovator samples and R&D formulations; compile and interpret analytical and statistical data; review and approve protocols, laboratory notebooks, reports, deviations, Out of Specification (OOS) and Out of Tolerance (OOT) investigations, specifications and analytical documents for method validation and ANDA submissions; conduct in vitro permeation test (IVPT) and in vitro release test (IVRT) Studies using radiolabeled and non-radiolabeled compounds; perform isolation and screening of microorganism and optimization of fermentation condition for maximum enzyme production; perform assay and impurities testing for drug products by using HPLC, UPLC, GC, LC-MS, GC-MS, UV-Vis, dissolution apparatus; and test elements’ contents by using ICP-OES, ICP-MS and HPLC-ICP-MS.
1. Master of Science or foreign equivalent degree in Chemical Engineering, Pharmaceutical Engineering or a related field.
2. 1-year experience in job offered or 1 year research experience. This required experience must include biohazard materials handling, biomaterial synthesis, enzyme metabolite & antioxidant isolation, purification and characterization, mechanistic modeling, method development, method validation, equipment qualifications, operation and troubleshooting of analytical equipment, evaporation, extraction, filtration, crystallization, distillation, titration, performing release and stability testing, impurity identification, component screening, qualification and cleaning validation. Experience can be gained while pursuing degree.
3. Proficiency in High Performance Liquid Chromatography (HPLC), Ultraviolet-visible (UV) Spectrophotometry, Gas Chromatography (GC), GCHD, Mass spectrometry (MS), ICP-OES, ICP-MS, dissolution apparatus, Empower, Chemdraw and MATLAB.