Fred Hutchinson Cancer Research Center
Process Development Scientist
Fred Hutchinson Cancer Research Center, Seattle, Washington, us, 98127
Overview
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.The Fred Hutch Therapeutic Products Program (TPP) Process Development (PD) group supports cell processing manufacturing activities for early-stage clinical trials, and performs technology advancement and development around cell therapy processes such as 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 manufacturing processes for Phase I/II clinical trials. Long term objectives are to develop efficient, cost-effective, and scalable processes so that these life-saving therapies are brought to patients in need.The Fred Hutch TPP PD group is seeking a
Process Development Scientist .Responsibilities
Strategize approach, develop methods, plan and execute experiments to design/develop operational processes, from conceptualization to experiment execution and analysis.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.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.Work closely and collaborate frequently with all TPP groups; Process Engineering, Manufacturing, Product Management, Quality Assurance and Quality Control.Use strong communication and teamwork skills to build relationships with all stakeholders.Support a culture of continuous improvement and a learning environment.Mentoring junior PD Associates or lab tech and helping them in their planning and activities.Understand and keep current on key areas of science and technology, anticipate changes and new directions in the field.Consistently exemplify Fred Hutch’s commitment to workplace respect, diversity, inclusion, and research and data integrity.Provide input to the department annual operating budgets.Evening and/or weekend work may be required from time to time.Qualifications
MINIMUM QUALIFICATIONS:Applicants must possess an BS degree in Immunology or a related field, and have a minimum of 4 years of proven experience.Hands-on experience in cell and gene therapy based processes including but not limited to CAR T, TCR T and NK cells.Hands-on experience in utilizing analytical methods to characterize processes including cell based assays, flow cytometry and proteomic/genomic methods.Able to independently design/execute/troubleshoot experiments with design of experiments(DOE) fundamentals and analyze/present data.Experience in designing and developing process for scale-up and technical process transfer into a GMP manufacturing environment.Strong ability to evaluate technical data and write technical documents.Strong ability in presenting information and data to technical and non-technical audiences.Excellent communication skills and careful attention to detail are also required.PREFERRED QUALIFICATIONS:MS or PhD degree in Immunology, Chemical Engineering, or a related field.Management of direct reports and mentoring staff members.Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.
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Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.The Fred Hutch Therapeutic Products Program (TPP) Process Development (PD) group supports cell processing manufacturing activities for early-stage clinical trials, and performs technology advancement and development around cell therapy processes such as 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 manufacturing processes for Phase I/II clinical trials. Long term objectives are to develop efficient, cost-effective, and scalable processes so that these life-saving therapies are brought to patients in need.The Fred Hutch TPP PD group is seeking a
Process Development Scientist .Responsibilities
Strategize approach, develop methods, plan and execute experiments to design/develop operational processes, from conceptualization to experiment execution and analysis.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.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.Work closely and collaborate frequently with all TPP groups; Process Engineering, Manufacturing, Product Management, Quality Assurance and Quality Control.Use strong communication and teamwork skills to build relationships with all stakeholders.Support a culture of continuous improvement and a learning environment.Mentoring junior PD Associates or lab tech and helping them in their planning and activities.Understand and keep current on key areas of science and technology, anticipate changes and new directions in the field.Consistently exemplify Fred Hutch’s commitment to workplace respect, diversity, inclusion, and research and data integrity.Provide input to the department annual operating budgets.Evening and/or weekend work may be required from time to time.Qualifications
MINIMUM QUALIFICATIONS:Applicants must possess an BS degree in Immunology or a related field, and have a minimum of 4 years of proven experience.Hands-on experience in cell and gene therapy based processes including but not limited to CAR T, TCR T and NK cells.Hands-on experience in utilizing analytical methods to characterize processes including cell based assays, flow cytometry and proteomic/genomic methods.Able to independently design/execute/troubleshoot experiments with design of experiments(DOE) fundamentals and analyze/present data.Experience in designing and developing process for scale-up and technical process transfer into a GMP manufacturing environment.Strong ability to evaluate technical data and write technical documents.Strong ability in presenting information and data to technical and non-technical audiences.Excellent communication skills and careful attention to detail are also required.PREFERRED QUALIFICATIONS:MS or PhD degree in Immunology, Chemical Engineering, or a related field.Management of direct reports and mentoring staff members.Publication of novel process improvements, meeting abstracts and/or talks, as appropriate.
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