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Associate Scientist - Chemistry

Edison-New Brunswick Metro Area, New Jersey

Post Date: 05/24/2017 Job ID: JN -052017-19126
Associate Scientist - Analytical Development
BS/MS in analytical chemistry or relevant discipline with equivalent experience.
Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience.
Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc.

Responsible for conducting and assisting with laboratory analysis for clinical supplies release and clinical supplies stability testing.
  • Conduct reference standards qualification analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical supplies testing for IND/IMPD/NDA submissions.
  • Participate and conduct validation analysis, clinical supplies testing and technical/methods transfer analysis all under GMP protocol driven processes.
  • Perform laboratory analysis and GMP testing under guidance of a supervisor or designee.
  • Clinical supplies release and stability testing for drug substance (API) and final formulated drug product, method validation analysis and support testing, reference standards qualification and analysis.
  • Able to conduct analytical experimental and/or GMP testing independently and may assist other analysts in analytical testing using analytical techniques and instrumentation including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis and other (compendial) analytical laboratory testing.
  • Conducts routine analytical experiments and GMP analyses using defined analytical methods and procedures such as finished products and API Assay, Related impurities and Dissolution testing.
  • Will also participate in feasibility and experimental method development designed to optimize and define analytical methods for further validation.
  • Performs instrument/method troubleshooting within analytical method parameters and management guidance (If needed for confirmatory or investigational testing).
  • Performs testing for development, clinical supplies release and stability samples in accordance with established methods, specifications and protocols under GMP with limited supervision.
  • Good laboratory documentation skills.
  • Strictly follows GMP testing and documentation requirements.
  • Documents/reviews laboratory work using laboratory notebooks/worksheets, ELN, LIMS and instrument electronic databases and integration programs that is detailed, timely and in compliance with GMP requirements.

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