Scientist
Scientist for Frontage Laboratories, Inc. - Exton, PA, perform assay and impurities testing for drug products by using HPLC, UPLC, GC and UV; perform immediate or extent release test with dissolution, paddle and basket apparatus; conduct HPLC-MS methods for non-UV absorb compound analysis and limit test; test elements contents by using ICP-OES, ICP-MS and HPLC-ICP-MS; analyze water content in drug samples; perform in-use study for injection products or lyophilized drug products; test assay and impurity of drug product in IV bags and infusion; resolve out of specification (OOS) and out of tolerance (OOT) investigations; operate lab equipment as per SOPs and manufacture recommendations; and perform all duties based on SOPs and GMPs
Requirements:
- Master of Science or foreign equivalent degree in Pharmaceutical Science or a related field.
- 1 year experience in job offered or 1 year experience as a Quality Specialist in GMP environment. This required experience must include issuing and approving controlled documents (e.g. deviation, investigation, change control forms), conducting QC checks on instrument parameters, file names and compound names against validated analysis methods for a variety of tests, auditing scientific reports, such as solid form screens, crystallization process development, water analysis by using Karl Fischer titrators, thermal analysis using TGA and DSC, unknown particle identification by polarizing light microscopy, stereomicroscopy, FT-IR micro-spectroscopy, mass spectrometry and NMR analysis to ensure compliance with SOPs and GMPs, supporting client audits and regulatory inspections such as the FDA, EU, EEA.
- Must be proficient in LIMS software and maintenance of controlled forms.