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Scientist I

2 months ago

Lakewood, New Jersey, United States Renaissance LLC Full time
Job Summary

Renaissance LLC is seeking a highly skilled Scientist I - Analytical R&D Specialist to support validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical projects.

Key Responsibilities
  • Support validation activities of analytical methods and method transfer from R&D to QC laboratories as per current SOPs, ICH and FDA guidelines.
  • Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing of R&D/engineering batches.
  • Use analytical techniques like HPLC/UPLC, GC using empower software, Karl Fisher, UV spectrophotometer, etc.
  • Author standard methods of analysis and review analytical test methods, reports, and protocols.
  • Operate all laboratory analytical instrumentation and perform troubleshooting and calibrations of laboratory equipment as needed.
  • Manage time effectively to complete assignments in an expected timeframe.
  • Document all experimental work neatly and correctly in a lab notebook in accordance with SOPs.
  • Review lab testing results and notebooks to ensure accurate documentation.
  • Maintain quality checks on safety of the lab, including biohazards and ensure maintenance of the facilities according to GLP.
  • Comply data and interpret any out of trend/specification against predetermined validation criteria and update R&D Management accordingly.
  • Effectively interact with other scientists, project managers, and colleagues from numerous functions.
Requirements
  • Bachelor's of Science Degree in Biochemistry or Chemistry.
  • 1-5 years of analytical laboratory experience in Pharmaceutical industry.
  • Experience with method validation is required and method development is preferred.