Senior Administrative Director, Therapeutic Products Program

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

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. 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.
Fred Hutchinson is seeking a Senior Administrative Director, Therapeutic Products Program (TPP). This program includes GMP manufacturing of clinical grade cellular and biological products, Quality Assurance, Quality Control, Immune Monitoring, Alliance/Project Management, and Process Development. The Senior Administrative Director, TPP will serve as the administrative partner for the Scientific Director and TPP Steering Committee; he/she will be expected to manage operations in an efficient and fiscally responsible manner with the overall goal of supporting the success of this critical strategic resource. Senior Administrative Director will partner closely with the Scientific Director to ensure the program is structured and operated in a manner that serves all the scientific and strategic goals of Center programs.

The Senior Administrative Director will have operational/financial oversight of seven core resources, including Cell Processing Facility, Biologics Production Facility, Quality Assurance, Quality Control, Immune Monitoring, Alliance/Project Management, and Process Development. The Senior Administrative Director will be responsible for the efficient production and quality of both research and clinical-grade cellular and biological products in a high-paced research environment. The Senior Administrative Director will work closely with the Scientific Director, TPP Steering committee, and individual faculty members to ensure TPP operations serve and anticipate customer needs. The Senior Administrative Director will have a dual report structure, reporting to the Fred Hutch Chief Operating Officer for operational and financial issues and to the TPP Scientific Director for scientific and regulatory components.

Specific responsibilities include
Leadership
- In collaboration with the Scientific Director, responsible for performance and support of all TPP Directors and the Manager of QA. The Senior Administrative Director will promote continuous development of a team of manufacturing and quality professionals.
- Strategic planning in collaboration with the Scientific Director and TPP Steering Committee. The Senior Administrative Director is expected to develop and optimize plans for staffing, plant operations, and finance that support strategic goals and ensure compliance with FDA and GMP regulations.
- The Senior Administrative Director will report quarterly to the TPP steering committee on current operations, finance, and future needs and plans for the facility.

Financial management and Business Development
- Responsible for operating and capital budgets in collaboration with the COO and representatives from Finance
- Develop and maintain appropriate rate structures, conduct yearly reviews of rates, and ensure timely and appropriate billing in all resources.
- In collaboration with the Scientific Director and TPP Steering Committee, assess new program opportunities and ensure robust support and collaboration with Alliance Management in coordinating contracts, developing budgets, and collaboration with all partners.

Operations
- Implement the overall strategy, priorities, and quality vision as set by the TPP Steering Committee. Responsible for management of physical plant, operations, and data systems.
- Ensure coordination of production scheduling, project planning and quality program structure in collaboration with the core Directors.
- Assess needs and potential to expand services in Project Management, Process Development, and Vector production in collaboration with the Scientific Director.
- Ensure appropriate Quality Systems are maintained, including ongoing data analysis of product and process outputs to ensure early detection of quality issues and response to quality improvement opportunities.

Customer Service
- Collaborate with all users of the TPP to ensure the highest possible quality in the facility, assess needs for operational changes, and cooperate with the Scientific Director and TPP Steering Committee to anticipate and plan for future operational requirements.

A Bachelor's Degree (Master's Degree or PhD preferred) with at least 5 years of experience in GMP manufacturing in either an academic setting or, preferably, within the pharmaceutical or biotechnology industry and 5 years professional experience managing 3-5 leaders of functional areas.

A high level of knowledge of cGMP and FDA requirements and guidance documents and a thorough understanding of quality systems is preferred, as is prior experience in managing inspections performed by the FDA and other regulatory authorities. Experience in the manufacturing of Cellular Therapeutic or Biological products is preferred.

The ideal candidate will have a demonstrated ability to:
- effectively lead individual teams as well as act collaboratively across an organization;
- establish timelines, benchmark accountability, oversee program and project budgets and set rates for projects of varying length and scope;
- develop and document procedures through strong project management skills and excellent written and verbal communication skills;
- analyze data and apply an analytical framework to decision making

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