Cures Start Here. AtFred 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 Hutchs 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 nations first and largest cancer prevention research program, as well as the clinical coordinating center of the Womens 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.
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.
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
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
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.