Staff Scientist, Process Development - Cell Processing Facility

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 the development, characterization and optimization of manufacturing processes and analytical methods for early-stage cellular and gene therapy clinical trials. PD works closely with internal Fred Hutch investigator laboratories and external collaborators to establish processes and analytical methods to support early phase clinical trials with the goal to provide robust processes for potential use in late stage development programs. This position will serve as the technical lead for development, characterization and advancements around selection, transduction, and ex-vivo expansion parameters for stem cells, T-cells, and B-cells. Primary objectives are to develop efficient, cost-effective, and appropriately scaled processes so that potential lifesaving therapies can be brought to patients in need.

This hands-on Staff Scientist position will provide technical guidance and scientific leadership to the PD group as well as 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 and clearly communicated. The successful candidate 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 include, but are not limited to:
- Act as the technical lead for the PD department in regards to the design, execution and analysis of complex, multi-factorial experiments.
- Partner with investigators in the development of processes that will meet unique clinical requirements, and address constraints associated with larger-scale manufacturing
- Provide well-organized presentation, rationalization, and explanation of the experimental design, resultant data analyses and conclusions
- Identify emerging technologies for process/analytical improvement, and champion their successful implementation
- Mentor PD staff on experimental design, data analysis and technical presentations
- Coordinate with project management and project sponsors to define the scope of development projects, including cost estimates, timelines and staff availability
- Use strong communication and teamwork skills to build relationships with stakeholders
- Provide input to the department annual operating budgets
- Represent PD and Fred Hutch at internal and external scientific meetings
- Evening/weekend work may be required based on project needs
- PhD in Biotechnology, Biological Sciences, or Chemical Engineering, with 3+ years of post-doctoral or industry-based experience in Process Development supporting cell culture based manufacturing operations
- Strong knowledge of cell therapy applications using T-cells/stem cells or recognizing that this is a nascent field, transferable skills from other biological fields
- Experience in the isolation and selection of primary cells (e.g. CliniMACS)
- Hands-on experience working with adherent and suspension cell cultures in flask and bioreactor systems including associated harvest and cryopreservation unit operations
- Prior experience in process characterization, scale-up and technology transfer
- Involvement in cell culture media development and optimization of cell culture processes and operating conditions
- Working knowledge and hands-on experience in the development, implementation and performance of analytical methods (e.g. flow cytometry, cell-based potency) to support cellular therapies
- 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 and allocations, timelines, and budget forecasting

Preferred:
- Demonstrated ability to resolve issues associated with process scale-up and transfer into a GMP manufacturing environment
- Previous project leadership or mentorship experience

To apply for this position, please CLICK HERE

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