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 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 Quality Control (QC) department performs in-process and release testing assays for a wide range of Phase I/II clinical products manufactured in both the Cellular Processing Facility (CPF) and the Biologics Production Facility (BPF). Products range from autologous T-Cell therapies (CAR-T, T-Cell Receptors, and Tumor-Infiltrating Lymphocytes) to complex biological products including lentiviral vectors, fusion proteins and monoclonal antibodies. The team also qualifies test methods and equipment to support these activities and actively supports regulatory submissions.
The Quality Control Manager reporting to the Head of Quality for the Therapeutics Product Program (TPP) will support the Phase I/II Cell Processing Facility (CPF) and Biologics Production Facility (BPF) operations. The QC Manager will interact with manufacturing personnel in the BPF and CPF, research scientists, physician investigators, Process Development, Quality Assurance and other scientific staff and external collaborators.
Lead and champion quality control system integration between the Cellular Processing and the Biologics Production facilities
Integrate the quality control role into the BPF organization
Champion proactive identification and resolution of compliance gaps
Create quality control programs as required
Provide quality control support to multiple areas within both manufacturing facilities
Support facility improvement projects
Ensure management and control of critical equipment within the QC laboratories
Aid in the enhancement of the Environmental Monitoring programs
Oversee the implementation and continual improvement of the QC systems.
Define and report on performance metrics measuring lab quality. Advises staff on areas for improvement, QC focus areas and efficiency in the quality control process.
Oversees the effective training of staff within the QC department. Prepare written procedures and training material.
Act as subject matter expert for Out of Specification investigations. Serves as lead for discussions regarding QC testing or investigations as they relate to clinical studies.
Responsible for personnel management of quality control associates inclusive of personnel scheduling, time management, performance management and ensuring career development opportunities in order to encourage employee retention.
BS or MS in Biology or related discipline.
Experience working in a regulated GMP environment.
Minimum of 5 years working in a quality role within a cellular therapy or biopharmaceutical organization.
Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
Ability to manage conflict.
Ability to work as a team member and to work collaboratively with strong listening skills.
Ability to translate strategic initiatives into tactical solutions.
Must be knowledgeable of FDA cGMP regulations and guidelines.
Ability to utilize elements of Quality Risk Management to manage and control risk.
Ability to effectively present complex data and strategy to large groups.
Proven track record in developing or leading teams.
Experience with flow cytometry, cell culture based functional assays (e.g. target cell killing, RT-PCR, ELISA, etc.).
Expertise in qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
Experience generating documents intended for use in a GxP environment or regulatory filings inclusive of DMF, IND and/or CMC.
Familiarity with data analysis/statistical software packages (e.g. FlowJo, Gen5, JMP, etc) desirable, but not required.
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Fred Hutchinson Cancer Research Center