Cellular Therapy Laboratory Manager/
Seattle

$1,000 Colleague Referral Bonus Program*

We are conducting an exclusive search to identify a seasoned professional to assume overall management

of the Cellular Therapy Laboratory (CTL) for the Seattle Cancer Care Alliance which 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 Children’s Hospital and Regional Medical Center.

The Cellular Therapy Laboratory (CTL) is responsible for all minimally manipulated therapeutic cell processing occurring at the Seattle Cancer Care Alliance (SCCA). Procedures range from cryopreservation to more complex procedures such as cell selection, enrichment, and depletion. The laboratory is regulated by the FDA, CGTP/cGMP standards, maintains CAP certification, and is accredited by the Joint Commission and FACT.

The Cellular Therapy Manager is responsible for the operational management of the SCCA Cellular Therapy Laboratory (CTL). The position reports to the Associate Director, Controlled Cellular Production in collaboration with the Laboratory Scientific Director and Medical Director. Regular interactions with medical, scientific, quality and research staff provide a stimulating and innovative environment

Interaction with other departments and laboratories in the SCCA and FHCRC Clinical Research Division, Basic Sciences Division, and Shared Resources Facility is inherent to the position to ensure coordination of workflow in the lab is at optimal level. Some patient contact may be required due to individuals assisting in the thawing and infusion of cryopreserved cells.

The ideal candidate will have previous managerial, organizational, strong communication and personnel management skills. . Change management and strategic planning experience would be a plus in this position. This position requires the ability to collaborate and communicate effectively with laboratory and quality system staff, health care professionals, researchers and across departments in a clinical research setting. This position also requires the capability to provide input on a global level within the SCCA and our partner organizations as well as at the detail level in the daily management of operations within the CTL.

Responsibilities:

• Leadership of laboratory operations to ensure quality, patient safety, efficiency and compliance with governmental regulations and guideline
• Responsibility for laboratory organization, personnel issues, including hiring, training, professional development, continuing education and disciplinary actions
• Direct the development, writing, revision, review and implementation of standard operating procedures (SOP). Identify and perform gap analysis in SOP development and review and implement corrective action in collaboration with the Controlled Cellular Production (CCP) Quality Department.
• Maintain understanding of CTL operations, procedures and technology.  Ensure in collaboration with CTL supervisors appropriate staffing ratios, role assignments and quality standards are met on a daily basis.
• Work in close collaboration with CCP Quality Department in the development of quality systems to ensure patient safety and compliance with applicable requirements, regulations and standards.
• Provide operational planning and support for projects within CTL and across SCCA departments for continuous quality and process improvement.
• Support the evaluation process in the development of a new laboratory information management system.
• Investigate clinical, technical and/or procedural problems or discrepancies.  Implement cost effective and business-orientated solutions.
• Consult and advise medical, clinical and research staff on methods and techniques.  Promote new innovative technology and advancements.
• Oversee in collaboration with CTL supervisors the evaluation, selection, validation and implementation of existing and new laboratory equipment.
• Promote a collaborative working environment with all SCCA programs and departments including financial and billing services.
• Development and monitoring of operating and capital budgets.  Analysis and report financial variances.
• Establish and enforce in collaboration with CTL management team departmental and SCCA policies and procedures.  Adhere to official standards and regulations in the areas of integrity, privacy, human resources and security.
• Collaborate with Laboratory Scientific Director, Medical Director, CCP Quality Department and SCCA Administration to develop short and long range plans for improving processes, systems improvements, clinical services and technological advancements provided by the CTL. Develop 2, 5, 7 year strategic plan.
• Promote change management activities in the areas of staffing, process development, product processing, inventory control, data management, & auditing.

Requirements:

• Baccalaureate degree in biological science or medical technology, and three years experience in cellular therapy, biotech, scientific laboratory or related field.
• A minimum of two years experience at the supervisor/manager level, with increasing levels of responsibility.
• Knowledge of FDA, cGMP, cGTP requirements, CAP, FACT standards for cellular therapy. Biotech industry or scientific laboratory preferred.
• Additional relevant regulatory or laboratory standards would be beneficial.
• Budget and revenue cycle experience is preferred.
• Knowledge and experience in project & change management is preferred.
• Experience related to laboratory information management systems would be beneficial.
• Able to work in ambiguous environments
• Able to create change by influence - - without direct line authority; needs connectibility
• Comfort around higher management
• Customer focus
• Skilled communicator and team player
• Keen analytic mind
• Needs a sense of urgency
• Must be able to engage people and lead thinking
• Have the ability to marry the abstract and reality

The ideal candidate will have previous leadership, organizational, communication and personnel management skills.  Overseeing the development of formal training programs that focus on cellular processing and administrative standards is required. Change management and strategic planning experience would be a plus in this position. This position requires the ability to collaborate and communicate effectively with laboratory and quality system staff, health care professionals, researchers and across departments in a clinical research setting.  This position also requires the capability to provide leadership on a global level within the SCCA and our partner organizations as well as at the detail level in the daily management of operations within the CTL.

Experience the very best in this Pacific Northwest Community’s unique settings. Blending rich cultural cosmopolitan living with small town traditions and the vastness of the great outdoors, colleges, universities, museums, artisans, theatre, and the symphony are part of a dynamic vibrant city.  Located in the Mountain’s shadow and surrounded by rivers, lakes with an easy drive to the ocean this area offers exceptional recreational activities and a quality of life found only in the Pacific Northwest.

*Refer a colleague and receive a $1,000.00 Bonus when your referral is hired.

Please send resume, visit our web site or
for a confidential conversation to discuss details contact:
Pat Holtermann - Holtermann & Associates – www.hva-jobs.com
pat@hva-jobs.com - 888-778-0098