Method Validation Research Chemist

Method Validation Research Chemists for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc.

Perform responsibilities in accordance with company policies, SOPs, + state, federal + local laws. Set up + operate analytical instruments for sample testing (i.e., HPLC, GC, IR, UV/Vis, AA, TLC + Distek/Agilent. Set up + operate analytical instruments for sample testing (i.e., UPLC + ICP- MS. Set up + operate analytical instruments for sample testing (i.e., Karl Fischer, Moisture Balance, Automatic/Manual Titration, Viscosity Meter, Density Meter + Malvern Particle Size Analyzer). Test raw materials (excipients + drug substance) release testing: assay, related substance, particle size distribution, loss on drying, water content, residual ignition, residual solvents, optical rotation, pH, viscosity according to the analytical methods, USP/EP compendial monographs, procedures in a regulated laboratory environment. Perform testing of In-process, drug products and/ or stability samples including assay, blend/ content uniformity, preservatives, related compounds, laser diffraction/ sieve analysis, bulk + tapped density + other tests according to the analytical methods in a GMP env. Perform testing of resin based extended-release Intermediates, resin based extended-release liquid/ solid dosage, form clinical study samples, cleaning verification/ validation methods, qualitative + quantitative analysis to support reference standard qualifications, method comparisons, method validation, verification + transfer. Prepare validation/ verification/ transfer protocols + reports. Perform analytical method interim validation. Analyze samples using appropriate instrumentation such as HPLC, UV, IR, KF, particle size analyzer, pH, etc. Process + report the analysis results using the instrument specific data processing software. Perform calculations associated with test analyses. Label, transcribe + record all testing details + results in laboratory notebooks + report sheets, compliant with current cGDPs, cGMPs + SOPs. Clean, maintain + calibrate laboratory instruments to ensure compliance with cGLPs + cGMPs. Clean + organize MV lab areas. Train + mentor junior chemists on instrument operation + maintenance. Participate in laboratory investigations + root cause determinations. Troubleshoot problems assoc w/ instrumentation, analytical anomalies + laboratory investigations. Track + maintain sample flow. Comply w/ Company policies + procedures, incl but not ltd to safety rules + DEA regulations. Meet project deadlines + performance standards. May undergo background checks incl drug screen. Wage: $113,589 - $127,500 plus comprehensive benefits (A complete list of benefits can be found at trispharma.com/connect/careers).