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At St. Jude Children's Research Hospital, we encourage you to dream big, and we give you everything you need to be the force behind our cures. We are looking for a Scientist IV-Quality Control to assist Children’s GMP, LLC at St. Jude Children's Research Hospital. The selected candidate will operate independently with minimal daily supervision to design methods for in-process, release and stability testing of biological products developed and produced in the Children’s Good Manufacturing Practices (cGMP) facility at St. Jude Children’s Research Hospital. The scientist will implements methods that meet Food and Drug Administration (FDA) regulatory requirements described in the International Conference on Harmonization (ICH) guidelines for biopharmaceutical products. Generates development reports that summarizes all work related to the development of a method, generates a Standard Operating Procedure (SOP), transfers the method, and trains the staff in the Quality Control (QC) laboratory to run the method. The scientist should have knowledge of and can perform analytical methods including gel electrophoresis, DNA/RNA extraction PCR applications, and tissue culture. The scientist must have the knowledge and ability to develop cell-based functional assays, ELISAs, product related residual testing.This scientist will interact closely with the Process Development group within the TPQ department on the development of release assays used to characterize the product during the production process or for product release.
The scientist will work closely with the Quality Assurance Group and Quality Control Manager in the generation of documents, such as SOPS, qualification protocols and the qualification of the methods. Experience with cGMP and procedures, aseptic technique, tissue culture, and Droplet Digital PCR (ddPCR) preferred. The scientist must be capable of learning software, manipulating formulas, and assessing correctness. The selected candidate should have a strong understanding of teamwork and have excellent communication skills.
The GMP team at St. Jude Children's Research Hospital (SJCRH) is looking for an outstanding Director of GMP Manufacturing. The selected person will manage all activities related to the cGMP manufacturing of biological products, including monoclonal antibodies, recombinant proteins, gene therapy vectors (Adeno-associated virus and Lentivirus), live viral vaccines for investigational use in Phase I and II human clinical trials at SJCRH. We are looking for someone who has appropriate experience managing cGMP operations, scientific expertise and knowledge 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). The Director of GMP Manufacturing will work closely with Process Development, Quality Control, Quality Assurance and Project Management on all aspects of cGMP manufacturing.