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Cell Therapy Lab Manager

Cell Therapy Lab Manager

Job ID 
10803
Type 
Regular Full-Time
Company 
Seattle Cancer Care Alliance
Location 
US-WA-Seattle
Category 
Executive and Management

More information about this job

Overview

Seattle Cancer Care Alliance (SCCA) is a leading healthcare organization that unites the doctors from Fred Hutchinson Cancer Research Center, UW Medicine, and Seattle Children's to form a world-class treatment center that provides advanced therapies and clinical studies for cancers and other blood disorders.

 

The Cellular Therapy Laboratory (CTL) at SCCA is responsible for all cell therapy-based procedures occurring at the SCCA. These range from standard cryopreservations to complex processing such as cell selections, enrichments, and depletions.  The laboratory is regulated by the FDA, cGTP/cGMP standards, maintains CAP certification, and is accredited by the Joint Commission and the Foundation for the Accreditation of Cellular Therapy (FACT).  

 

Position Description

  • Position Title: Manager, Cellular Therapy Laboratory          
  • Reports to: Associate Director, Cellular Therapeutics                              
  • Directly supervises: Supervisor, Assistant Supervisor, and Senior Technologists (5 FTE)           
  • Management and Additional (Indirect) Supervision of: Approximately 20 staff, including technologists and coordinators.

Essential Position Purpose:

 

The CTL Manager is a key position, responsible for the overall management of the SCCA CTL. The position reports to the Associate Director of Cellular Therapeutics (CTP). Regular interactions with medical, scientific, quality and other administrative staff in multiple departments and organizations within the Alliance as well as external collaborators provides a stimulating and diverse environment.

 

The nature of this work is challenging and we are seeking a highly motivated individual with initiative, subject matter expertise, management, mentoring, leadership, team-building and team work experience. The work requires mature judgment, decision-making capability and outstanding communication skills. Effective cross-functional collaboration with other departments at the SCCA, FHCRC and with external organizations is necessary to the position. This includes being comfortable and conversant with clinical issues: able to interact with clinical peers/counterparts.  Overseeing the development of formal training programs that focus on cellular processing and administrative standards are required. 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 detailed level in the daily management of operations within the CTL. Change management and strategic planning experience are required in this position.

 

 

Responsibilities

Essential Position Accountabilities

  • Leadership and management of laboratory operations to ensure quality, patient safety, efficiency and compliance with standards, regulations and guidelines.
  • Demonstrate the SCCA values and help colleagues as a Servant Leader.
  • Develop and maintain effective working relationships with a variety of colleagues and stakeholders across departments and organizations.
  • Management of staff, including hiring, training, professional development, mentoring, continuing education and corrective counseling.
  • Understand CTL operations. Manage the writing, review and implementation of standard operating procedures (SOPs) in CTL. Identify and perform gap analysis in SOP development and review and implement corrective action in collaboration with the Quality Department.
  • Maintain understanding of necessary scientific theory, terminology and practice at a level to be able to educate and guide staff and work effectively with technical experts. This includes learning about new cell-based therapeutics entering clinical trials in which CTL participates.
  • Consult with clinical and research staff and seek out literature on methods and techniques.  Promote new innovative technology and advancements.
  • Serve as a key member of CTP Leadership in establishing vision, strategic initiatives and project prioritization for the department.
  • Participate in CTL capacity planning and action, including recruiting, retaining and educating staff.
  • Provide operational planning and support for projects within CTL and across SCCA departments for continuous quality and process improvement.
  • Maintain understanding of regulatory requirements & regulations including cGTP, FDA, FACT, CAP & other standards. Prior experience with accreditation and inspections preferred.
  • Work in close collaboration with CTP Quality Department in the development of quality systems to ensure patient safety and compliance with applicable requirements, regulations and standards.
  • Support development of a new laboratory information management system.
  • Support investigation of clinical, technical and/or procedural problems or discrepancies.  Implement cost-effective solutions.
  • Support business development efforts
  • In collaboration with CTS and CTL staff, assist in the evaluation, selection, validation and implementation of existing and new laboratory equipment.
  • Assist CTP Administration in development and monitoring of operating and capital budgets and analysis of financial variances.
  • Establish and enforce departmental and SCCA policies and procedures.  Adhere to official standards and regulations in the areas of integrity, privacy, human resources, safety and security.
  • Promote change management activities in the areas of staffing, process development, product processing, inventory control, data management and auditing.
  • Deal with situations that arise off-hours.
  • Assist with laboratory processing when volume demands it.

Qualifications

Position Competencies & Requirements

 

Education

  • Baccalaureate degree (BA or BS) in biological science or medical technology

Experience

  • At least five years’ experience in cellular therapy (research, development and/or manufacturing), both theory and practice
  • Hematology, oncology and/or immunology knowledge preferred
  • Budget and revenue cycle experience is preferred.
  • Knowledge and experience in project and change management is preferred.
  • Lean Leader training preferred
  • Experience related to laboratory information management systems
  • Monitoring and adjusting staff workloads appropriately
  • At least four years’ supervisory experience
  • Experience coaching and engaging in corrective counseling of staff preferred

Knowledge, Skills and Abilities

  • Ability to communicate and encourage shared values and goals
  • Ability to alternate between being a leader and a team player
  • Ability to collaborate, communicate and be accountable
  • Comfortable working and leading in a changing environment
  • Ability to identify and communicate priorities
  • Ability to navigate through, but not avoid, conflict
  • Strong track record of encouraging top talent
  • Ability to motivate and develop high-functioning teams
  • Strong work ethic
  • Strong decision-making skills in high risk, time sensitive situations
  • Ability to deal with complex problems and propose creative solutions

Please submit your resume with a cover letter.

 

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.