• Process Development Associate

    Job ID
    14564
    Type
    Temporary 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.

     

    An Associate position is immediately available in the Process Development 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. TPP includes facilities that provide assistance and service in process development, quality assurance (QA) quality control (QC) and production of biologics and cells according to Good Manufacturing Practice (GMP).

     

    As a Process Development Associate, you will act as a key individual and team contributor within the lab with respect to coordinating activities, ensuring standardized procedures/data analysis, generating technical reports, and defining overall operational efficiency. This position interacts heavily with internal and external research scientists, GMP manufacturing staff, Analytical Development/Quality Control, Quality Assurance, and other scientific staff, as needed.

     

    PLEASE NOTE: Funding for this term-limited position is available through October 2020. It is possible that during that time this individual may be considered for a permanent position, pending performance, should an opening become available.

    Responsibilities

    This position involves the development and optimization of cell processing unit operations including cell selections from starting tissues, genetic modifications (viral transduction, electroporation, etc.), expansion conditions, media/cytokine optimization, cell harvests, cryopreservation, and freeze-thaw recovery. In addition, this position assists in the development of robust and repeatable analytical methods to characterize starting, in-process and final, formulated cellular products.

     

    This position will also be involved in the phenotypic characterization of cell therapy products. Accordingly, strong skills in flow cytometry and functional cell-based assay design will be required to be successful in this role. Overall, development activities generate robust, scalable processes to support toxicology studies, transfer and product introduction into a GMP Cell Processing manufacturing facility, and IND generation to enable clinical trial initiation.

    Qualifications

    Minimum qualifications:

    • BS/BA in an engineering or biological sciences discipline plus 2+ years of related experience supporting GMP cell culture based manufacturing operations
    • MS (or higher) in an engineering or biological sciences discipline plus 1+ years of related experience supporting GMP cell culture based manufacturing operations
    • Experience in one of the following technical areas:
      • static and/or suspension cell cultures in flasks and bioreactors (fed-batch; fixed and/or disposable bioreactor systems)
      • cell culture media development and optimization studies
      • culture of primary cells (e.g., T-cell culture and maintenance)
      • cryopreservation and recovery of frozen cells
      • flow cytometry (e.g., concepts, multi-color staining panels, and experience analyzing data using FLOWJO or other software packages)
    • Familiarity with trouble-shooting issues associated with process scale-up and transfer into a GMP manufacturing setting; experience generating process transfer documentation
       

    Preferred qualifications:

    • 3+ years experience in process development and supporting GMP cell culture-based manufacturing operations. The ideal candidate will have experience in cell therapy applications with T-cells and stem cells
    • 1+ years representing the Process Development function on CMC project teams
    • Experience working with adherent and suspension cell cultures in various flask and bioreactor systems (fed-batch/perfusion; fixed/disposable)
    • Involvement in cell culture media development and optimization of cell culture processes and operating conditions
    • Experience with cell culture associated unit operations such as tangential flow filtration for cell harvest/concentration, centrifugation, and cryopreservation/thaw recovery
    • Knowledge of more complex analytical methods to characterize processes including cell based assays, multi-color flow cytometry, and proteomic/genomic methods; prior development/optimization of these methods highly preferred
    • Familiar with the resolution of issues associated with process scale-up transfer into a GMP manufacturing environment
    • Experience with design of experiment (DOE) fundamentals and resultant data analysis (e.g. JMP)
    • Ability to perform short- and long-term project planning in terms of the generation of scope of work documents and project plans, resource demands, time-lines, and budget forecasting
    • Ability to prioritize multiple tasks, work under various time-line pressures, and drive tasks to completion

    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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