Lab Chemist - TMT

Job Description:

• Knowledge of IS, ASTM & ISO certification, and SOPs for paint testing
• Manage an analytical laboratory, which include SEM-EDS, GC-MS, GPC, FT-IR, ICP-MS, TGA and DSC equipment.
• Manage projects including implementation of proactive chemistry changes on all product lines resulting in reduce environmental impact while delivering cost-savings.
• Conduct GC-MS, TGA, and FTIR, UV/Vis spectroscopic analysis of extractables and elemental impurities.
• Project Leader/System managermanage method development and validation projects on HPLC and GC.
• Prepare submission documentation, including CMC sections, for IDE and PMA submissions.
• Perform routine maintenance/troubleshooting on 5890 GC's with FID, PID, and ECD detectors.
• Analyze a diverse platform of drug product and API at a CMO and drug development company.
• Operate and maintain various chemical instrumentation including GC, FT-IR, UV-VIS, AA and others.
• Work on method development to transfer drug assays from older equipment to new HPLC and UPLC equipment.
• Replace and align a laser and power supply on an FTIR instrument saving $2,000 and several days of downtime.
• Develop high throughput certify and validate quantitative methods in support of non-GLP, GLP and human clinical studies using LC/MS/MS.
• Develop and revise QC systems such as sampling, sample tracking, reserve inventory, control substance inventory and stability.
• Authore and implement training modules for QC laboratory.
• Perform qualification, troubleshooting and maintenance on HPLC instruments.
• Perform multiple GLP pesticide registration research studies and validations.