Staff Scientist Process Development, Cell Therapy

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 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 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 life-saving therapies can brought to patients in need. Evening and/or weekend work may be required from time to time

This Staff Scientist position will provide technical expertise to the PD group as well provide technical support for the 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 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.
• 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
• Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.

Required qualifications

• Ph.D. degree in Immunology, Microbiology, Molecular Biology, Cell Biology, or Biotechnology
• 3+ years of experience in process development or research laboratories supporting T-cell based processes (CAR-T, TCR, NK, TIL, etc.).
• Experience in the isolation of primary cells from starting tissue (e.g. CliniMACS separations)
• 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. degree in immunology
• Strong expertise in CAR-T cell therapy development and optimization
• Experience in supporting GMP cell culture-based manufacturing operations. The ideal candidate will have experience in cell therapy applications with T-cells and stem cells.
• Involvement in cell culture media development and optimization of cell culture processes and operating conditions
• Experience working with adherent and suspension cell cultures in various flask and bioreactor systems (fed-batch/perfusion; fixed/disposable)

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 [email protected] or by calling 206-667-4700.