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Form of workDescription
QC Lab Operation Chemist for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Test raw materials, in-process, finished product + stability samples, incl dissolution, assay, content/blend uniformity, particle size distribution, + other tests to accord w/ analytical methods, USP, procedures in regulated lab environment. Perf preservatives testing, Related Compounds analysis, Laser Diffraction/Sieve Analysis, Bulk and Tapped density, cleaning verification/validation + other tests to accord w/ analytical methods in GMP environment. Analyze + interpret test results. Analyze samples using approp instrumentation, incl HPLC, UV, IR, KF, + pH. Process + report analysis results using instrument specific data processing software. Operate analytical instruments incl Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet Visible Spectroscopy (UV/Vis), moisture balance, automatic titration, Infra-Red Spectroscopy (IR), Malvern Particle size analyzer, Thin Layer Chromatography (TLC) + Dissolution Apparatus (Distek). Assess equip perf. Execute equip qual protocols. Train + mentor jr chemists on instrument oper + maint. Eval instrument perf + troubleshoot instrument malfunction. Process + report calibration results using instrument specific data processing software. Complete timely compendial review to maintain QC lab compliance, + work w/ rel departments (AR&D + MV) on compendial review actions. Assist lab investigations + root cause determinations. Troubleshoot problems w/ instrumentation, analytical anomalies, + lab investigations. Meet pjct deadlines + perf standards. Adhere to cGMPs + cGDPs. May undergo drug screening.
Requirements
Must have Master's in Chem or rel sci field and 1 yr rel laboratory exp in pharmaceutical industry with cGMP requirements. Also requires skills (1 yr exp) in: working with analytical instrumentation in a pharmaceutical company; handling extended release intermediates, extended release oral suspensions and extended release powder for suspensions; handling immediate release oral suspension or oral solutions; interpreting analytical results and performing laboratory investigations; analytical method verifications and method transfers; performing routine metrology, calibration, maintenance and troubleshooting of analytical instrumentation in cGMP laboratory; and Microsoft Office. Alternatively, must have Bach in Chem or rel sci field and 3 yrs rel laboratory exp in pharmaceutical industry with cGMP requirements. Also requires skills (3 yrs exp) in: working with analytical instrumentation in a pharmaceutical company; handling extended release intermediates, extended release oral suspensions and extended release powder for suspensions; handling immediate release oral suspension or oral solutions; interpreting analytical results and performing laboratory investigations; analytical method verifications and method transfers; performing routine metrology, calibration, maintenance and troubleshooting of analytical instrumentation in cGMP laboratory; and Microsoft Office.
