Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Fred Hutch Cell Processing Facility (CPF) performs cGMP manufacturing activities for cell therapy clinical trials involving the selection, genetic modification, and ex-vivo expansion of stem cells, T-cells, and B-cells. The CPF works with both internal Fred Hutch investigators and external collaborators to manufacture cellular products in support of early phase clinical trials and development programs.
The Cellular and Gene Therapy GMP Manufacturing Director will provide direct technical and managerial leadership to the CPF and Process Development groups as well as indirectly to the entire cell therapy development network. The responsibilities of primary importance are to ensure the successful and time-sensitive GMP manufacture and release of cell therapy products, promote a culture of quality and compliance, and achieve continuous improvement. The position will involve managing manufacturing operations and the supervision of approximately 20 manufacturing staff with 4-5 direct reports and 4-5 Process Development Staff. The successful applicant will interact on a daily basis with clinical trial sponsors, QA/QC, research scientists, project management, and senior members of Fred Hutch faculty and administration. This position will report to the Therapeutics Products Program Director.
Specific responsibilities include:
- Provide senior leadership for the CPF and PD departments including hiring of manufacturing staff and providing mentorship and staff development
- Use of strong communication and teamwork skills to build relationships with stakeholders
- Demonstrate outstanding technical acumen, operational understanding and GMP compliance in the maintenance and continued expansion of the Cell Processing Facility
- Lead the improvement and implementation of all GMP procedures and policies related to Manufacturing operations
- Identify and mitigate risks in manufacturing operations that could adversely impact project outcomes and timely delivery of critical treatment to patients
- Champion the implementation of new technologies and systems
- Foster a culture of strong GMP compliance
- Ensure all staff maintains appropriate level of training and meets compliance standards
- Establish and effectively manage project-specific and departmental annual operating budgets for the Cell Processing Facility
- Evening and/or weekend work may occasionally be required based on project need
- A BS degree in bioengineering or the biological sciences
- At least 8 years of experience in cell culture based GMP manufacturing operations and cell culture based manufacturing methods, which may include cell selections, cell culture, harvest and cryopreservation
- Experience in cell therapy applications with T-cells and stem cells. However, recognizing that this is a nascent field, the candidate may have transferable skills from other biologics fields
- At least three years of managing a multi-product GMP manufacturing facility involving the complex scheduling and coordination of staff, materials, and manufacturing operations
- At least three years of experience of direct supervisory experience of technical professionals and in providing guidance, mentorship and support to direct reports so that they can best manage their teams and projects
- Expert knowledge of FDA regulations, GMP systems and operational excellence required for the manufacture of therapeutic products
- Demonstrated ability to perform long-term project planning with meaningful timelines and budget forecasting
- A MS or PhD degree with equivalent professional or academic experience
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