This position is involved in the Children's GMP, LLC (cGMP) manufacturing of patient-specific cellular gene therapy products. This position is part of a cGMP cellular gene therapy (CGT) manufacturing team that works closely with the Experimental Cellular Therapy (ECT) group that is responsible for the development of cellular gene therapy products. The ECT is responsible for transfer of the processes into cGMP manufacturing and training the cGMP CGT manufacturing team to insure transfer, training, and early manufacturing. The cGMP CGT manufacturing team, under the direction of the CGT Director, is responsible for the cGMP manufacturing of all cellular gene therapy products used by St. Jude Children's Research Hospital in Phase I/II clinical trials. Experience in maintaining mammalian culture, excellent tissue techniques required. Maintains processes according to the requirements as mandated by the FDA, FACT, EMA and MHRA. Maintains excellent documentation of records, GMP documents and generates reports that summarize all activities. Develop production batch records based process development activities in collaboration with the Quality Assurance Department of Children's GMP, LLC. If needed, provides support in the development of cellular therapies.
Eight (8) years of related experience with a BS. Four (4) years of related experience with a MS. No related experience required with a Ph.D. Experience in process development in a cGMP environment is preferred
Bachelor's degree in Biological Sciences, Chemical Engineering or Bioprocessing or related field required
MS or Ph.D. preferred.
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