• QC Associate III-IV, Cell-based Potency or Flow Cytometry

    Job ID
    14298
    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 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.

     

    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.

    Responsibilities

    • 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.

    Qualifications

    QC Associate III:

    • Bachelor’s 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:

    • Bachelor’s 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.

     

    Preferred Qualifications:

    • 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.

    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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