Senior Scientist I - GMP

Sep 16, 2016
Oct 14, 2016
Clinical, Research
Result Type
Position Type
Full Time
Summary:?? ? ?

The Senior Scientist I works independently 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 (SJCRH). Uses 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 (EMEA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Works as a member of a team responsible for manufacturing processes that meet the requirements for drug substance and drug products as mandated by the Food and Drug Administration. Documents work in a cGMP environment as required by cGMP protocol. Assists in developing production batch records and standard operating procedures. Works with the Manager of cGMP manufacturing to develop production-associated documents to support successful manufacture of products. Provides training to appropriate production personnel.

? ? ? ??Minimum Education:?? ? ?

Bachelor's degree in a scientific field required. Degree in Biotechnology, Chemical Engineering or Bioprocessing preferred

? ? ? ??Minimum Experience:?? ? ?

A minimum of eight (8) years of relevant post-degree work experience required with a bachelor's degree in a scientific field. A minimum of four (4) years relevant post-degree work experience required with a master's degree in a scientific field. No previous work experience required with a master's degree in Bioprocessing. No previous work experience required with a Ph.D. in a scientific field

? ? ? ??EEO:?? ? ?

St. Jude is an Equal Opportunity Employer

? ? ? ?? ? ?Not ready to apply? Become a St. Jude Career Insider to stay up-to-date on our opportunities.? ? ?