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Snr Associate Scientist -Cell Based Assay Development

Philadelphia Metro Area, Pennsylvania

Post Date: 06/30/2017 Job ID: JN -062017-19429 Industry: Analytical Chem - Scientific
  • M.S. degree with 3 or more years of cell based assay experience in analytical and biological laboratory
    Working knowledge of CGMP compliance and ISO9000
    Motivated and self-driven
    Working knowledge of CGMP and other regulatory and safety standards is preferred
  • Development, optimization and validation of cell-based assays for biologic product lot release, stability, comparability, biosimilarity, reference standard qualification, and forced degradation studies
    Transfer and maintenance of stable cell lines
    Development of cell based assays with broad experience in microplate reader, fluorescence, luminescence, reporter gene, mesoscale, cell-based AlphaLISA, flow cytometry and FRET
    Analysis of potency and parallelism of dose response curves using 4PL parameters and parallel-curve models, etc.

    Experience in design of experiment software (e.g., JMP)
    Experience of molecular biology, including gene transcription, protein expression, qPCR, Western blotting, immunoprecipitation, etc.
    Documentation to support CGMP and regulatory filing
    Provide assistance to project management to ensure meeting the requirements of project quality and timelines
    Maintenance of instruments, and address technical and instrumental troubleshooting issues
    Assist the Principal Investigator with study conduct
    Maintain study documentation
    Meet regulatory compliance requirement
    Maintain a safe work environment

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