The Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch's global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Quality Control laboratory performs in-process and release testing in support of Human Gene Therapy Phase I/II clinical research studies.
We are looking for a dynamic, skilled, and detail-oriented candidate to join our team. The position will perform routine cell-based potency assays, as well as microbial safety assays utilizing ELISA, microscopy, and qPCR techniques. In addition, the position will be required to follow and maintain laboratory quality systems in our GMP environment. Eventually, the position may also be required to train on flow cytometry-based methods.
Analytic Developer/Quality Control Associate I:
Perform routine microbiological, flow cytometry and cell culture based potency assays in support of manufacturing and process development activities.
Perform method development including assay qualification and generation of approved test methods.
Further responsibilities include sample receipt/distribution, communication with internal/external laboratories, environmental monitoring activities and maintenance of the lab equipment in state of regulatory compliance.
Analytic Developer/Quality Control Associate II:
Perform in-process, lot release, and stability cGMP testing of raw materials and human gene therapy products
Review assays performed by peers
Write SOPs and test methods
Perform deviation and out of specification (OOS) investigations
Maintain laboratory cell lines
Participate in environmental monitoring activities
Perform general activities in accordance to SOPs and laboratory quality system
Analytic Developer/Quality Control Associate I
At least a minimum of one year of experience in analytical methods used in QC release testing and characterization of immune cells and/or stem cells
Hands on experience with analytical methods that such as: FACS, cell culture based functional assays (e.g. target cell killing, cytokine release), quantitative PCR, genetic and proteomic profiling, ELISA
Experience in following and completing GMP test methods and documentation intended for product release testing and characterization as required under FDA and ICH guidelines
Experience in executing protocols for the qualification/validation of methods and equipment
Good communication skills and writing ability
Familiarity with data analysis software packages and general statistical concepts and methods
Bachelor's degree (or higher)
Analytic Developer/Quality Control Associate II
Bachelor's degree in a life sciences field with 2+ years, preferably with a background in biologics and/or cellular therapeutics
Hands-on experience with microtiter cell-based assays
Experience with aseptic and cell culture techniques
Experience with typical GMP Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.)
Good written and oral communication skills
Strong communication and writing skills with demonstrated ability to work in a dynamic team environment
Experience with cytotoxicity, bacterial endotoxin, and qPCR testing
Experience with Environmental Monitoring (EM) programs
Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at firstname.lastname@example.org or by calling 206-667-4700.
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.