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.
A Biologics Associate III position is immediately available in the Clinical Biologics Production group within the Therapeutic Products Program (TPP), a Fred Hutch Department supporting the development and manufacturing of novel biological molecules and innovative cell-based therapies for Phase I/II clinical testing in support of cancer therapy and vaccine development. TPP includes facilities that aid in Process Development, Quality Assurance, Quality Control and production of biological and cellular therapeutics according to Good Manufacturing Practice (GMP).
The Biologics Associate III is responsible for all aspects of product production, from cell culture scale up through production in bioreactors (or other technologies) to product purification. Products include biological therapeutics such as monoclonal antibodies, plasmids and viral vectors for clinical research use.
Formulation of buffers and following standard procedures for cell culture batch production
Scale up of cell culture and purification procedures from research levels to production levels
Harvest cell cultures at appropriate production levels
Developing purification schema appropriate to each product
Adapt alternative technologies to support production activities
Train and supervise personnel, including cross training to provide backup capabilities
Assist with and/or handle performance evaluations
Assist in scheduling production operations and forecast product delivery dates
Assist Senior Management with the development of documentation for resource operations, including batch records and standard operating procedures
Monitor and maintain equipment including autoclaves, bioreactors, incubators and chromatography equipment
Assist with facility cleaning, culture vessel depyrogenation, assembly and sterilization
Interface with and assist Quality Control in coordinating product testing and facility monitoring
Work with senior staff in determining long-term goals and laboratory needs and in setting operating policies
Bachelor's degree in Life Sciences, Chemical Engineering or related and a minimum of 3-5 years' professional experience in a lab using aseptic technique to culture mammalian cells
Ability to work independently
Experience in conflict resolution, team work and excellent interpersonal communication skills
Ability to work a standard M-F, 8AM-5PM schedule including occasional weekend days or evenings (~1-2 days per month)
6-8 years' experience in pharmaceutical (biologics) manufacturing
Experience with protein purification preferred
Familiarity with multiple technologies for culture of hybridomas and other mammalian and prokaryotic (bacterial cell culture; fermentation) cells at various scales of production
Experience with DNA plasmid prep and viral vector production
High level of comfort in dealing with specialized mechanical and electronic equipment
Working knowledge of Good Manufacturing Practices (GMP) and FDA guidelines
Familiarity with disposable technologies such as Single Use Bioreactors
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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.