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Sr. Scientist I GMP Manufacturing

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.The GMP Manufacturing department at St. Jude Children's Reserach Hospital is looking for a Sr. Scientist I to mainly assist with the process development and cGMP manufacturing of Influenza seed stocks. The successful candidate will have excellent aseptic techniques, the ability to work in an independent fashion with minimal daily supervision on the manufacturing of biological products, including monoclonal antibodies, recombinant proteins, gene therapy vectors (Adeno-associated virus and Lentivirus), and live viral vaccines for Phase I and II human clinical trials at St. Jude Children's Research Hospital. Has appropriate scientific expertise and understanding of the regulations governing the production of biopharmaceuticals as mandated by the United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Manufacturing processes will meet the requirements for drug substance and drug products as mandated by the Food and Drug Administration.

The responsibilities for the Sr. Scientist will hold the following responsibilities:


  • Works on the process development and cGMP Manufacturing of Influenza seed stocks in BSL2/BSL3 labs and cGMP manufacturing for both Drug Substances (bulk) and Drug Products (vialed product).
  • Run tech transfer and scale-up runs in the cGMP suite(s).
  • Understand and assist in developing production batch records. Suggest revisions and updates to SOPs related to the operation of production equipment, facilities, cGMP utilities, and procedures to the manager of cGMP manufacturing.
  • Operate cGMP manufacturing equipment and control software for buffer preparation, manufacturing of the drug substance (bulk) and drug product.
  • Ensures cGMP manufacturing suites are cleaned and released by QA prior to initiating cGMP manufacturing campaigns.
  • Collaborates with the Director of cGMP manufacturing to develop, write and revise Master Batch Production Records (MBPR).


    • B.S. required with M.S. or Ph.D. in biological sciences, with a preference in biotechnology, chemical engineering or bioprocessing


      • With a B.S., 5 years of laboratory experience is required, preferably in cGMP Manufacturing.
      • With a M.S. or Ph.D., 1-2 years of experience in bioprocessing or cGMP manufacturing is preferred.
      • Upstream and Downstream cGMP experience in the biotechnology industry or other GMP facility 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 GMP Manufacturing, Other , Raleigh, North Carolina

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