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Sr Scientist I-Quality Control

Company: St. Jude Children's Research Hospital
Location: Raleigh
Posted on: September 14, 2020

Job Description:

With resources to help you succeed and develop your career, we also offer generous relocation assistance.This position designs biological and analytical methods for in-process, release and stability testing of biological products developed and produced in the GMP facility at St. Jude Children's Research Hospital. Position is responsible for assay development and assay qualification as per FDA and ICH guidelines. Skills sets can include, but are not limited to, cell-based assays, capillary electrophoresis, analytical chemistry, molecular biology, and biochemistry. The position requires the technology transfer of assays from the laboratories of internal principal investigators and outside entities and to develop an experimental plan to further develop the method so it can be used for either release or characterization of the products. Ensures method meets the requirement established by the Food and Drug Administration and International Committee on Harmonization guidelines for a fully qualified assay. Assists in the development of in-process assays that are used to quantitate and characterize the product during the production process. Generates documents including Standard Operation Procedures (SOPS), qualification protocols and the qualification analytical methods. Ensures the appropriate Quality Control personnel receive training on relevant developed methods. In addition, maintain and operate equipment for flow cytometry-based assays.


  • Bachelor's degree in biochemistry, chemistry or analytical chemistry or related field required
  • Experience in flow cytometry highly preferred


    • A minimum of eight (8) years of analytical research experience is required with a Bachelor's degree
    • A minimum of four (4) years of analytical research experience is a required with a Master's degree
    • No experience is required with a Ph.D
    • Experience in cell-based biological assays, HPLC methods, capillary electrophoresis and standard compendia protein assays is preferred
    • Experience in tissue culture and development of biological assays is preferred
    • Experience in a GMP compliant environment is preferred

      St. Jude is an Equal Opportunity EmployerNo Search Firms:St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

Keywords: St. Jude Children's Research Hospital, Raleigh , Sr Scientist I-Quality Control, Other , Raleigh, North Carolina

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