Director of GMP Manufacturing
About the Job
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.
• Lead a talented and motivated manufacturing team of 7 staff.
• Develop appropriate documentation required for cGMP activities.
• Manufactures both drug substance (bulk) and drug product (aseptic processing).
• Subject matter expert on equipment and electronic systems used in cGMP manufacturing.
• Reviews data, accesses issues and devises strategies to solve problems.
• Manages and communicates effectively to the cGMP staff the goals and objectives of a project.
- Master's degree in a scientific field required
- PhD preferred
- Master's degree in a scientific field and 10 years of experience in cGMP manufacturing.
- Ph.D. in a scientific field and 4 years of research experience in cGMP manufacturing.
- Must have experience and knowledge in the scale-up and cGMP manufacturing of biotherapeutics and expertise in either biochemical engineering or bioprocessing, and a strong educational background in the biological sciences.
- Experience managing a team.