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 St. Jude GMP is transitioning to an electronic, FDA compliant environment, with GxP computerized systems meeting 21 CFR Part 11. The System Analyst GMP (SA-GMP) will become the subject matter expert for supporting GxP compliant computerized applications. Will work with the TPQ Bio-Process Information System team in the design, configuration, validation and maintenance of commercially available GxP compliant software solutions which meet the regulatory and business needs of the St Jude GMP Facility. Will work closely with cross-functional teams to develop, implement, and support project/process specific software applications that satisfy St Jude GMP business needs for an Electronic Batch Record (EBR), Quality Control testing and release of biotherapeutics manufactured by Children's GMP, LLC for Phase I and Phase II clinical trials. Will work directly with the Director of Quality Assurance to insure GxP compliance of the software applications. Will aid in the configuration and administration of the commercial systems (LIMS/ELN, etc.) to develop system functionality to meet end-user needs in a 21 CFR Part 11 compliant environment. Processes system changes, documents configuration, write and executes test plans, train end-users and is responsible for the overall health of the electronic system and the overall life-cycle management of validated software applications. Collaborates with cross-functional teams and external vendors to deliver complete research data delivery.