Job Details

  • Title: Associate Scientist
  • Code: RCI-6827
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 01/13/2020
  • Duration: 36 Months
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  Job Description

The Impurities Group supports the testing of large molecule in-process and drug substance samples for analytes such as host cell proteins, protein A, and residual DNA. The testing of impurities is a critical step in the large molecule drug development process.

  • Working in this position will carry out quantitative polymerase chain reaction (qPCR) assays to test for residual host cell DNA in biologics
  • Developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative impurities assays and supporting regulatory submissions
  • Perform qPCR assays and other analytical tests to measure process-related impurities in samples undergoing purification process development and communicate results to internal clients
  • Sample testing, method execution, operation of PCR instrumentation, troubleshooting, data analysis, documentation of results, report writing, and assay transfer activities
Basic Qualifications
  • BS or MS degree in Biology, Biochemistry, Biological Engineering or Analytical Chemistry
  • At least 1 full year of experience required:
    • Quantitative polymerase chain reaction
    • Good communication skills (both written and verbal)
    • Lab experience (can come from course work)
  • ELISA experience is a plus
  • Familiarity with method development, method qualification, electronic notebooks, and cGMP requirements are desired
  • Should be highly organized and motivated, have strong communication and presentation skills and the ability to multi-task, and collaborate and work in teams
  • Experience in a Biopharmaceutical working environment