This position is involved in the cGMP manufacturing of patient-specific cellular gene therapy products. The selected person will be part of a cGMP cellular gene therapy (CGT) manufacturing team that works closely with the Experimental Cellular Therapy (ECT) group responsible for the development of cellular gene therapy products. The cGMP CGT manufacturing team, under the direction of the Processing Facility Director, is responsible for the cGMP manufacturing of all cellular gene therapy products used by St. Jude in Phase I/II clinical trials.
The Sr. Scientist I would have the following duties:
- 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.
- Bachelor’s degree in Biological Sciences, Chemical Engineering or Bioprocessing or related field required
- MS or Ph.D. preferred.
- 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.
- Experience in maintaining mammalian culture and excellent tissue techniques is highly preferred.
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