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.
The Fred Hutch Therapeutic Products Program (TPP) encompasses two, distinct, clinical manufacturing facilities in support of Phase I/II clinical trials. Trials consist of both internal, faculty-driven protocols as well as external partnerships with peer institutions and industry partners.
The 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. Similarly, the Biologics Production Facility (BPF) performs cGMP manufacturing activities in support of Phase I/II clinical trials involving monoclonal antibodies, fusion proteins, plasmids, Lentiviral vectors and similar, mammalian and bacterial-based cultures.
Reporting to the Sr. Administrative Director of TPP (with a dotted-line reporting to the Chief Ethics and Compliance Officer), the responsibilities of the Head of Quality are to provide leadership, direction, and coaching to the site quality organizations. This individual will be responsible for leading the day to day Quality Operations for Quality Assurance, Document Control and Quality Control. Responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with Phase I/II GMPs. Additional responsibilities include team building, career development, assisting with financial reviews, establishment of annual budgets and identification and rollout of yearly goals and objectives and longer-term strategic plans for the departments.
The position will involve managing multiple staff members across the quality organization including direct-line supervision of Managers/Sr. Managers in QA and QC along with responsibility for Document Control personnel.
The successful applicant will interact on a daily basis with clinical trial sponsors, manufacturing, research scientists, project management, and senior members of Fred Hutch faculty and administration.
Specific responsibilities will include: