Staff Scientist, Process Development (Cell Therapy)

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

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 scaleable processes so that these lifesaving therapies can brought to patients in need.

This Staff Scientist position will provide technical services to the PD group as well as to the entire Cellular Processing Facility. The position will ensure that development activities are aligned with manufacturing needs, experiments are appropriately designed, and that results are effectively communicated. 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. This position will report to the Cellular Processing Facility Director.

Specific responsibilities will include:
- Provide support to the PD department in the design, execution and analysis of experiments and also provide well-organized and coherent presentation of the experimental data and outcomes
- 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 staffing availability
- Use strong communication and teamwork skills to build relationships with stakeholders
- Provide input to the department annual operating budgets
- Complete responsibility for the department operating budget
- Evening and/or weekend work may be required based on project needs

Required
- PhD in Engineering or the Biological Sciences
- At least five years of post-doctoral or professional industry-based experience in process development supporting GMP cell culture based manufacturing operations
- Experience in cell therapy applications with T-cells and stem cells; or, recognizing that this is a nascent field, transferable skills from other biologics fields
- Experience in the isolation of primary cells from starting tissue (e.g. CliniMACS separations)
- 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 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

Preferred
- Previous leadership or mentorship experience

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