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Associate Scientist

Newark Metro Area, NJ

Post Date: 04/10/2017 Job ID: JN -042017-18799 Job Type: Other

  • Responsible for assisting with laboratory analysis for clinical release and clinical stability testing.
  • Conduct reference standards qualification analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical testing for NDA submissions.
  • Participate in validation, clinical testing and technical transfer analysis.
  • Perform laboratory analysis under guidance of a supervisor or designee.
  • Responsibilities will include, but are not limited to, the following: clinical release and stability testing, method validation support, reference standards qualification.
  • Able to conduct testing independently and may assist other analysts in analytical testing including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis and other analytical laboratory testing.
  • Conducts routine analytical experiments using analytical methods and procedures such as finished products and API Assay,
  • Related impurities and Dissolution testing.
  • Draws basic conclusions from data and results and communicates with other analysts and management.
  • Performs instrument/method troubleshooting within analytical method parameters and management guidance (If needed for confirmatory or investigational testing).
  • Performs testing for development, release and stability samples in accordance with established methods, specifications and protocols with limited supervision.
  • Good laboratory documentation skills.
  • trictly following cGMP in reference to testing and documentation requirements.
  • Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with cGMP requirements.

Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience.
Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc.
Good communication skills.
Able to work well in team environment to achieve results.
Exhibits sound scientific judgment based on reasonable assumptions and available information.

BS/MS in analytical chemistry or relevant discipline with equivalent experience.

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