Director of GMP Operations - Clinical Manufacturing
The Director of GMP Operations is responsible for the overall operational management of the Good Manufacturing Practices and Clinical Manufacturing Facility (GMP). Working in close collaboration with the Scientific Directors specific to production lines (e.g., gene therapy, cell-based therapies, tissue engineering, and monoclonal antibodies), the Director will oversee all day-to-day GMP operations, including project and time line management, budget, personnel, facility management, and Quality Control. The Director is responsible for insuring the GMP delivers all products in a timely, compliant, and fiscally responsible fashion.
- Directs the day-to-day operations of the GMP facility and all associated activities through both hands-on activities and supervision of GMP staff.
- Works with the production line Scientific Directors to develop and enact strategic direction for the GMP, including the determination of project priorities and time lines.
- Oversees all GMP resources, including production, facilities, and Quality Control, to meet production goals in alignment with the objectives of the Scientific Directors and the strategic plan and scientific objectives of The Research Institute and NCH.
- Is responsible for sound project and financial management of the GMP, including preparation of and adherence to budgets and standards for cost measurement. Directs operations so as to remain within approved budgets and time lines.
- Plays strategic role in estimating future capacity, serving as primary liaison with suppliers and purchasing staff.
- Manages and drives all operation related functions to optimize GMP efficiency.
- Supervises and assists in daily operational activities related to the GMP manufacturing of biological products, including gene therapy vectors (e.g., Adeno-associated virus and Lentivirus), live viral vaccines, cell-based therapies (cultured and genetically-modified hematopoietic stem cells for clinical and investigational use in Phase I and II human clinical trials), tissue engineering, recombinant proteins, and monoclonal antibodies.
- Develops and implements GMP policies and procedures that ensure production activities are compliant with Institute and all governing regulatory, environmental, and safety directives.
- Insures that appropriate and accurate documentation surrounding GMP activities supporting product quality is maintained.
- Provides sponsors and collaborators with timely production status reports.
- Tracks daily work flow. Anticipates and resolves project issues.
- Must have significant experience in GMP operations, an understanding of a variety of GMP product lines, and knowledge in the scale-up of biotherapeutics.
- Proven ability in bioprocess development to improve and refine scalable production processes for increased biologic yield, purity, and quality in a GMP environment.
- Demonstrate knowledge of regulations governing the production of biopharmaceuticals as mandated by governing bodies (e.g., FDA, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
- Minimum of 3 years of experience in bioprocess engineering or bioprocessing.
- Advanced degree in in biological sciences or engineering.
- Proven ability to improve biological process efficiency.
- Substantial experience in the direction and supervision of staff in a biomedical research environment.
- Demonstrated experience in budget management and business development.
- Demonstrated ability to make timely decisions.