Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

Cell Therapy Project Coordinator I

Job ID
18000
Type
Regular Full-Time
Company
Seattle Cancer Care Alliance
Location
US-WA-Seattle

Overview

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.


The Cellular Therapeutics Department (CTP) at SCCA is one of the largest cell therapy facilities in the United States and is on the cutting edge of new technologies for cancer therapy, including cell-based immunotherapy. We are committed to advancing treatment options for our patients through the translation of innovative research into clinical practice. We collaborate with our Alliance members (University of Washington, Fred Hutch, and Seattle Children’s Hospital) as well as corporate entities.


CTP is responsible for all minimally manipulated therapeutic cell processing occurring at the SCCA for standard practice as well as clinical trials. Procedures range from cryopreservation and flow cytometric enumeration of cell proportions to more complex procedures such as cell selection, enrichment, and depletion. The laboratory is regulated by the FDA cGTP/cGMP standards, maintains College of American Pathologists (CAP) certification, and is accredited by the Joint Commission and the Foundation for the Accreditation of Cell Therapy (FACT).

 



The Project Coordinator is an integral member of the CTP team, collaborating across functions which include the Apheresis Group (APH), Cell Therapy Laboratory (CTL) and Quality as well as across organizations within and outside the Alliance. The primary responsibilities of this position are to manage equipment for APH and CTL, to coordinate and track training, and to participate in a variety of cell therapy projects relating to both operations and administration. The position reports to the Associate Director of Cellular Therapeutics (CTP). Regular interactions with medical, scientific and quality staff provide a stimulating and diverse environment.


We are seeking a highly motivated individual with initiative, excellent communication and collaboration skills, consummate professionalism and attention to detail. While specific experience with cell therapy operations or administration is a plus, it’s possible to learn about this field on the job. The qualified applicant should be dedicated to serving patients and SCCA’s vision to lead the world in translating scientific discovery into the prevention, diagnosis, treatment, and cure of cancer. The qualified applicant will be someone who is at ease working either independently or as part of a team.


Employees must adhere to all SCCA policies and processes, including the SCCA Code of Conduct and all HIPAA privacy requirements.

Responsibilities

  • Become familiar with operations for cell-based therapy at SCCA
  • Maintain equipment management program
  • Assist with clinical lab equipment validations
  • Contribute to change management process: writing change control reports and evaluating the validation requirements for various types of proposed changes
  • Provide input to operating and capital budgets 
  • Become integral team member for CTP projects, including process improvement using Lean Principles
  • Develop and maintain effective working relationships with a variety of colleagues and stakeholders, including cross-functionally
  • Identify process improvements, facilitate development and documentation
  • Write, revise, review and implement standard operating procedures (SOP)
  • Maintain understanding of necessary scientific theory, terminology and practice at a level to be able to 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.
  • Adhere to official standards and regulations in the areas of integrity, privacy, human resources, safety and security
  • Apply knowledge of relevant FDA, CAP, JC and FACT requirements and standards and participate in inspections
  • Maintain programs and databases for training coordination
  • Continually learn about cell therapy theory and practice, demonstrated in the application of the knowledge to operations support
  • Coordinate Cell Therapy Services projects, as assigned
  • Work with cross-functional teams to support newly implemented processes and help to address any corrective issues
  • Must be able to work onsite at the SCCA South Lake Union Campus

Qualifications

Required:

  • Baccalaureate degree (BA or BS)
  • Experience preparing and reviewing regulated documents
  • Knowledge of basic regulatory standards
  • Experience interacting effectively with vendors
  • Experience related to laboratory information management systems beneficial
  • Strong business communication skills
  • Strong skills with Microsoft Excel and Word

 

Preferred:

  • Clinical laboratory equipment and/or materials management 
  • Training/experience with regulated therapeutics either in a laboratory or administrative role
  • Project coordination experience; project management a plus
  • formal communications training 
  • Meeting facilitation skills 
  • Hematology, oncology and/or immunology knowledge 
  • Knowledge of regulatory requirements and standards for cell-based therapy or biologics 
  • Experience working with quality systems 
  • Biotechnology or other scientific laboratory experience 
  • Knowledge of Lean or Six Sigma Principles
  • Diversity and Inclusion education/training 
  • Lab Management Systems, particularly Labware
  • CPI Fundamentals training
  • Experience in GLP, GTP or GMP environment

Critical Success Factors:

  • Highly invested in and motivated by SCCA’s mission to turn cancer patients into cancer survivors
  • Initiative
  • Self-motivated
  • Ability to work independently with minimal supervision
  • Attention to detail
  • Outstanding organizational skills
  • Outstanding communication skills
  • Ability to work effectively with diverse professionals across functions and organizations
  • Ability to collaborate and be accountable
  • Ability to identify and communicate priorities
  • Ability to navigate through, but not avoid, conflict
  • Strong work ethic
  • Ability to deal with complex problems and propose creative solutions

 

Please submit your application with cover letter.

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed