• Process Development Director/Sr. Staff Scientist, Cell Therapy

    Job ID
    14241
    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 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 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. Evening and/or weekend work may be required from time to time.

    Responsibilities

    This Sr. Staff Scientist/Process Development Director position will provide technical and managerial leadership to the Process Development group as well as serve as a technical resource for the entire cell therapy organization.  The position will ensure that development activities are well aligned with manufacturing needs, experiments are appropriately designed, and that results are effectively communicated to key stakeholders.  The successful applicant will interact on a daily basis with clinical trial sponsors, manufacturing, QA/QC, research scientists, project management, and senior Fred Hutch faculty and administration. 

     

    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 senior leadership for the PD department including hiring and management of staff and providing mentorship and staff development
    • 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.
    • Partner with GMP manufacturing staff to ensure appropriate transfer of needed process and analytical information for successful clinical material production
    • Use strong communication and teamwork skills to build relationships with stakeholders (e.g., faculty, research staff, GMP manufacturing associates, etc.)
    • Provide input to (and be responsible for) the department annual operating budgets
    • Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.

    Qualifications

    Minimum qualifications:

    • Ph.D. in immunology, bioengineering, cellular biology, microbiology or related field plus one or more years of GMP or GMP-related (e.g., tech transfer) experience
    • 7+ years of research experience in immunology, cell biology or related field that would support process development role
    • Experience with primary cells (e.g., T cells, B cells, stem cells, etc) and their isolation from primary sources, such as tissue and apheresis (e.g., CliniMACs), retroviral or lentiviral vectors and transductions systems
    • Experience with retroviral or lentiviral transduction systems
    • 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
    • Familiar with the resolution of issues associated with process scale-up and 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 qualifications:

    • Ph.D. in Immunology
    • Strong expertise in CAR-T cell therapy development and optimization
    • 10+ 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; however, recognizing that this is a nascent field the candidate may have transferable skills from other biologics fields
    • 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

    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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