Senior Process Development Associate
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 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.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
Working under the direction of the Process Development (PD) Director within the Therapeutic Products Program (TPP), the 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.
Responsibilities
The Senior Process Development Associate will:
- 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
- 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.)
Qualifications
- BS in immunology, biology, chemical engineering or related scientific field
- 5+ years of experience in process development
- Direct experience in a process development environment supporting aseptic cell culture based manufacturing operations including 2+ years hands-on experience with B-cell/T-cell/stem cell isolation and expansion protocols
- 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)
- 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
- 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
- Must be able to communicate effectively in a diverse team environment in support of team goals
- Must demonstrate solid time management and organizational skills, with good verbal and written communication
- Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
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 hrops@fredhutch.org or by calling 206-667-4700.