• Biologics Associate III

    Job ID
    14809
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Manufacturing
  • 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.

     

    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).

    Responsibilities

    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             

    Qualifications

    Minimum:

    • 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)

     

    Preferred:

    • 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

    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 escmail@fredhutch.org or by calling 206-667-4700.

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