Fred Hutchinson Cancer Research Center Senior Manager, Cellular Therapeutics in Seattle, Washington
The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.
Cellular Therapeutics (CTP) is comprised of four functional groups with responsibility for the production of clinical cellular products for patient treatment: Apheresis Unit at SCCA, Cellular Therapy Laboratory (CTL), Quality Assurance (QA), and Cellular Therapy Services (CTS).
The Senior Manager, Cellular Therapeutics role is an integral part of the CTP leadership team. This position is expected to bridge departmental operations, scientific direction and administration, provide continuous connection between individual services within CTP, working in a collaborative relationship with SCCA leadership toward a shared mission and vision.
The CTL is responsible for all minimally manipulated therapeutic cell processing occurring at the SCCA for both standard therapies and clinical trials including immunotherapies. Procedures range from cryopreservation and flow cytometric enumeration of cell proportions to more complex procedures such as cell selection, enrichment, and depletion for manufacture of immunotherapies. In addition, CTL stores and prepares for infusion a variety of externally manufactured cell-based therapeutics, including FDA Approved CAR T cells. The CTL is regulated by the FDA cGTP/cGMP standards, maintain College of American Pathologists (CAP) certification, and is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT).
The nature of this work is challenging, and the position requires individual initiative and decision-making capabilities to carry out the required tasks. The work requires mature judgment for the development of appropriate technical, scientific and business initiatives and in recognizing circumstances requiring special attention. Flexibility in scheduling is required. Interaction with other departments and laboratories in the SCCA, Fred Hutch Clinical Research Division, UW Medical Center and external organizations/institutions is inherent to the position. The position requires excellent written and verbal communication skills.
Oversee operations of the CTL and CTS
Develop tactical and strategic goals, project portfolios.
Provide operational and administrative oversight of CTL and CTS by establishing procedures and practices, along with validations, qualifications, investigations, and planned and unplanned variances.
Facilitate operational decision and efficient utilization of resources to provide timely and accurate services. Oversight of implementation of new technologies and instrumentation.
Ensure departmental projects are well managed and executed within established timeline and budget.
Oversee and support implementation of clinical trials in CTP. Facilitate contract management for clinical trials utilizing services provided by CTL.
Ensure effective communication between various departments within CTP. Provide CTP representation to multiple forums across the SCCA and our partner organizations
Foster a culture of continuous performance improvement; provide leadership and support to move CTL initiatives forward; ensure CTL interests are well represented in cross-departmental projects
Responsible for personnel issues, including hiring, performance management and disciplinary actions. Mentor staff and managers and provide opportunities for leadership development. Ensure effective staff recruitment, training, career development and retention.
Participate in development of departmental budget. Assure financial performance and evaluate capital expenditures. Monitor and reconcile fiscal performance of the department.
Work in collaboration with the CTL Scientific Director, Medical Director and QA Associate Director to provide cross-departmental oversight and guidance for quality, safety and compliance with applicable standards, laws and regulatory mandates related to CTP.
Participate in development of comprehensive productivity metrics. Ensure tracking and trending analysis and provide recommendations for improvement in the CTL.
Establish and promote educational activities to encourage a learning culture for CTL staff and management.
Work with CTP leadership and managers to ensure regulatory and accreditation compliance.
Bachelors degree in biological science, epidemiology, public health, business or equivalent
Seven or more years of progressively responsible management experience in the health care/laboratory field
Seven or more years of experience with cellular therapeutics, both theoretical and practical in the laboratory or 10+ years' experience in biologics research and development and/or manufacture
Practical expertise in cell-based therapeutics, processes and manufacturing in a clinical cell therapy laboratory
Extensive and progressive administrative experience with at least five years as a Manager or above level in clinical research or as a laboratory services leader
Solid track record of effective management. Experience mentoring front line staff and supervisors, developing staff competency at all levels. Experience in creating a highly accountable and high performing team and staff is essential.
Experience in an environment where clinical trials are administered in the patient care setting. Working knowledge in the implementation and conduct of clinical trials
Working knowledge of FACT standards, cGTP, cGMP, and related FDA regulations
Excellent operational skills and the ability to execute a strategy
Proven experience working effectively with physicians and other scientific and clinical leaders in a multi-disciplinary environment and across organizational lines to achieve excellent outcomes
Ability to work in a rapidly changing environment
Experience in budgeting, forecasting, strategic fiscal planning, and the use of decision support systems, benchmarks, and metrics to guide operating decisions
Proficiency in use of performance improvement tools and techniques to improve staff engagement and job satisfaction
Communicates effectively at all levels in the organization. Articulate and poised with well-developed presentation skills, both verbal and written
Experience with process and equipment validations. Working knowledge of laboratory equipment management
Working knowledge of cell-based therapeutics contracts for lab services
Experience in a large, complex ambulatory cancer center is desired. Ideally there will be experience in the academic and research environment
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