Job Description

Assist Chemist in planning and executing laboratory tests according to test procedures. Conduct chemical experiments under the guidance of Head Chemist. Document test procedures and results and report the same to Head Chemist for analysis.

• 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.

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