• Quality Control Associate III-IV, Flow Cytometry

    Job ID
    11709
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Quality
  • Overview

    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 and largest 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 FHCRC 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.  The group also develops and transfers new analytical methods used to characterize products, and support process development and product comparability.  In addition, the group qualifies test methods and equipment to support these activities and actively supports regulatory submissions.

    Responsibilities

    The Quality Control Associate will primarily focus on the development and performance of analytical test methods, primarily flow cytometry, in a GMP laboratory environment. The position is required to follow laboratory quality systems and support routine maintenance of the lab to ensure a continued state of regulatory compliance.

     

    • Develop and implement GMP flow cytometry assays for new cell therapy protocols.
    • Perform GMP lot release and in-process flow cytometry testing of raw materials, intermediates, and final cell therapy products.
    • Perform cell-culture based assays including target cell killing, cytokine release, etc.
    • Perform assays such as gram stain, MycoAlert, MycoSEQ PCR, endotoxin, and microscopic analysis as opportunity allows.
    • Author test methods and associated SOPs.
    • Maintain instrumentation and supporting documentation per GMP requirements.

    Qualifications

    Required:

     

    • BS/MS in a biological science with 6+ years of relevant experience in analytical testing including flow cytometry and/or a background in biologics and/or cellular therapeutics.
    • Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.

     

    Preferred:

     

    • Experience with the Miltenyi MACSQuant flow cytometer preferred but not required.
    • Experience with RT-PCR and cell culture based functional assays (e.g. target cell killing, cytokine release, etc.).
    • Experience working in a regulated (GxP) environment.
    • Experience generating documents intended for use in a GxP environment or regulatory filings.

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.

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