Job Title: Sr. Staff Scientist, Process Development
Fred Hutchinson Cancer Research Center
Seattle, WA US
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Sr. Staff Scientist, Process Development
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.
This Staff Scientist position will provide technical leadership to the PD group as well as serve as a technical resource for the entire cell therapy organization. The scope and responsibilities for this position and management of direct reports will depend upon the experience level of the candidate. 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 and leadership 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.
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 the department annual operating budgets
Depending upon the qualifications of the candidate, other responsibilities may include:
Management of direct reports and mentoring staff members
Complete responsibility for the department operating budget
Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.
Minimum qualifications include:
Ph.D. in immunology, bioengineering, cellular biology or related field plus one or more years of GMP or GMP-related (e.g., tech transfer) experience
3+ 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
Ideal qualifications include:
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; 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
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 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
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