This position designs biological and analytical methods for in-process, release and stability testing of biological products developed and produced in the GMP facility at St. Jude Children's Research Hospital. Position is responsible for assay development and assay qualification as per FDA and ICH guidelines. Skills sets can include, but are not limited to, cell-based assays, High Performance Liquid Chromatography, capillary electrophoresis, analytical chemistry, molecular biology, and biochemistry. The position requires the technology transfer of assays from the laboratories of internal principal investigators and outside entities and to develop an experimental plan to further develop the method so it can be used for either release or characterization of the products Ensures method meets the requirement established by the Food and Drug Administration and International Committee on Harmonization guidelines for a fully qualified assay. Assists in the development of in-process assays that are used to quantitate and characterize the product during the production process. Generates documents including Standard Operation Procedures (SOPS), qualification protocols and the qualification analytical methods. Ensures the appropriate Quality Control personnel receive training on relevant developed methods.
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 and
Directs the coordination of activities related to the testing, release, and stability testing of biological products for investigational use in human clinical trials. This position is also responsible for oversight of biological assay development, including but not limited to cell-based, flow cytometry, PCR, ELISA, and coordinating outside testing activities (adventitious agent testing, DNA sequencing, etc). This position requires an in-depth knowledge in the Biological Sciences (virology, cellular biology, biochemistry and microbiology), Analytical Chemistry and Biochemistry, and current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) regulations. The Director of Quality Control will be expected to maintain an extensive knowledge and expertise in Federal Regulations and International Conference on Harmonization (ICH) guidelines pertaining to the testing and release of biological products for clinical trials and the appropriate scientific expertise to evaluate product quality. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment, within generally defined practices and policies, in selecting methods and techniques for obtaining solutions. This position is subject to extended hours and callback as needed. Requires an individual with proven technical skills and management skills in the analysis and testing of biologics manufactured under cGMP and current Good Tissue Practice (cGTP), production and scale-up in one or more of the following areas.