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Sr. Scientist I (ARD)
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Full-time
- ResponsibilitiesExecute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelinesIndependently develop and evaluate methodologies, design and implement experiments.
- Maintains compliant records with little or no supervisionAble to write technical documents with assistanceStrong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructionsSets up various instrumentation for testing according to written test methods and with little to no supervision.
- Responsible for ensuring compliance with cGMP and other regulatory guidelines.
- Qualifications/SkillsWorking knowledge of experimental design, including chemistry supporting method developmentWorking knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC.Working exposure to cross functional techniques including organic chemistry.
- Understands the chemical properties relating to method development, qualification /validation and troubleshooting.
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