• Staff Scientist, Process Development

    Job ID
    12118
    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 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 Process Development (PD) group within the Therapeutic Products Program (TPP) supports cell processing and manufacturing activities for early-stage cell therapy clinical trials, and performs technology advancement and development around selection, transduction, and ex-vivo expansion parameters of NK cells, stem cells, T-cells, and B-cells. PD works closely with internal Fred Hutch investigators and external collaborators to establish processes for early phase clinical trials as well as late stage development programs that may eventually lead to commercialization. Long term objectives are to develop efficient, cost-effective, and scalable processes so that these lifesaving therapies can brought to patients in need.

    Responsibilities

    Specific responsibilities will include:

    • Provide technical expertise for the PD department in the design and analysis of experiments and in presenting resultant data to groups outside of the department in a succinct, well-organized and coherent manner
    • Provide analytical characterization expertise in techniques such as flow cytometry, mass cytometry (CyTOF), genomic analysis (e.g., PCR and sequencing), etc.
    • Development of analytical methods and transfer into QC environment for routine testing
    • Identify opportunities for process improvements and champion their successful implementation
    • Partner with investigators in the development of processes that will meet their clinical requirements and address constraints associated with larger-scale manufacturing
    • Coordinate with project management and project sponsors to define the scope of development projects, including cost estimates and timelines
    • Use strong communication and teamwork skills to build relationships with stakeholders (e.g., faculty, research staff, GMP manufacturing associates, etc.)
    • Provide input to the department annual operating budgets

     

    Depending upon the qualifications of the candidate, other responsibilities may include:

    • Management of direct reports and mentoring staff members
    • Publication of novel process improvements, meeting abstracts and/or talks, as appropriate

    Qualifications

    Minimum:

    • Ph.D. in Immunology or related field plus relevant professional experience in engineering or biological sciences
    • 1-3 years of experience with analytical characterization techniques, such as flow cytometry, mass cytometry (CyTOF), DNA/RNA sequencing, etc
    • Experience in the isolation of primary cells from starting tissue (e.g. CliniMACS separations)
    • Experience with retroviral or lentiviral transduction systems
    • 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 analytical methods to characterize processes including cell-based assays, flow cytometry, and proteomic/genomic methods; prior development/optimization of these methods highly preferred
    • Analytical development experience assessing assay qualification parameters, such as range, linearity and precision
    • 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, timelines, and budget forecasting
    • Ability to prioritize multiple tasks, work under various timeline pressures, and drive tasks to completion

     

    Preferred:

    • 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
    • Direct CAR-T or engineered TCR experience and proven track record of characterization of complex cellular therapy products
    • Bioassay experience for development of both plate-based and cell-based assays to characterize key components of cellular therapy products (e.g., purity, potency and safety)

     

    Pay, Benefits, and Work Schedule:

    • Full time position
    • Salary commensurate with experience + excellent benefits

     

    Evening and/or weekend work may be required from time to time

    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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