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.
Fred Hutchinson Cancer Research Center's Quality Control laboratory performs in-process and release testing assays for T-cell and stem cell therapeutic products manufactured in the GMP Cell Processing Facility for Phase I/II clinical trials.
The Quality Control Associate will primarily focus on the development and performance of cell-based potency, ELISA assays or Flow Cytometry in a GMP laboratory environment. Many other types of assays are performed and cross-training on other assays is required. The associate will transfer, perform, and troubleshoot new and existing assays with a high level of independence while working on multiple projects, serve as the subject matter expert and technical lead for clinical GMP testing. The associate will also serve as the key point of contact for principal investigators and research lab staff.
Perform and analyze GMP in-process and lot release testing of cell therapy products for Phase I/II clinical trials by following standard operating procedures (SOPs).
Collaborate with team members to meet required testing timelines.
Perform peer data review.
Author or revise test methods, standard operating procedures, and training modules.
Transfer methods in collaboration with principal investigator and/or industry partners.
Analyze data for trends and make recommendations to principal investigator or management.
Troubleshoot complex problems that may impact test performance and results.
Participate on cross-functional projects and teams.
Maintain lab equipment per established procedures.
Identify and support deviation investigations & CAPAs.
Maintain instrumentation and supporting documentation.
Train staff on technical and operational procedures.
QC Associate III:
Bachelors degree in life sciences field with 5+ years GxP experience required
Proficiency in running cell-based potency, ELISA assays or Flow Cytometry, experience with industry standard aseptic techniques and cell culture maintenance is required.
QC Associate IV:
Bachelors degree in life sciences field with 8+ years GxP experience required
Proficiency in running cell-based potency, ELISA assays or Flow Cytometry experience with industry standard aseptic techniques and cell culture maintenance is required.
Mastery of aseptic technique, cell based potency, ELISA method or Flow Cytometry development and validation/qualification.
Extensive experience generating GMP documentation and systems.
Detail oriented, organized, proactive and self-motivated.
Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment while meeting acceptable timelines.
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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.