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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The primary responsibility of a Cellular Production Associate is to execute manufacturing operations in the production of modified cellular products for patients participating in Fred Hutchinson Cancer Research Center cell therapy clinical protocols. Clinical manufacturing in the Cell Processing Facility (CPF) requires following applicable current Good Manufacturing Practices (cGMP) in a cleanroom processing environment.
Shift Available: Tuesday Friday, 7:00AM 5:30PM
Utilizing aseptic techniques, perform a variety of open cell product manipulations in an ISO 5 biosafety cabinet.
Follow Standard Operating Procedures (SOPs) and complete required processing documentation such as production batch records.
Perform cell processing operations such as cell selection/depletion, expansion, stimulation, transduction, cryopreservation, and preparing patient infusions.
Perform routine review of executed GMP process documentation.
Submit deviation documentation and complete deviation investigations and reports.
Maintain and operate primary process equipment, such as incubators, centrifuges, cell sorting/selection equipment and controlled rate freezers.
Take an active role in problem solving and troubleshooting of cell processing operations and equipment.
Evaluate current practices and operations and implement changes to improve performance.
Participate in Corrective and Preventative Actions (CAPA) development and completion, and GMP Systems change control.
Participate in quality/compliance improvement and technical development projects.
Provide guidance and training to junior staff.
Work with Process Engineering and GMP Systems to lead equipment on-boarding and validation projects.
Act as Protocol Champion, assigned to specific clinical protocols as a point of contact for manufacturing readiness and execution, reporting out production status and production run summary data as needed.
Lead by example and take responsibility in the support of safety and cGMP compliance
Bachelor's degree in a biological science and one year of postgraduate lab experience required. Relevant experience in lieu of degree is acceptable.
Experience with cell culture.
Must be able to support and communicate effectively in a diverse team environment.
Must be able to work efficiently, with strong attention to detail in a highly regulated environment.
Must demonstrate solid time management and organizational skills, and good verbal and written communication.
Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all required Personal Protective Equipment (PPE).
Must have the ability to stand for long periods.
Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
Ability to work non-standard shifts and occasional weekend days or evenings.
3+ years'experience as a production associate for cGMP Cell Therapy product production.
Mastery of open aseptic processing, working in biosafety cabinets.
Establishing and maintaining long-term T-cell lines/clones preferred.
Experience writing or revising standard operating procedures, manufacturing batch records, and other GMP Systems documentation.
Computer skills highly desirable (MS Office).
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.