Cell Therapy Specialist III

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. 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.

The Cellular Therapy Lab (CTL) at Fred Hutch Cancer Center 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 consortium partners (University of Washington and Seattle Children's Hospital) as well as industry (biotechnology) and non-industry external entities. CTL is responsible for all minimally manipulated therapeutic cell processing occurring at Fred Hutch. Procedures range from cryopreservation to flow cytometric enumeration of cell proportions to more complex procedures such as cell selection, enrichment, and depletion. The laboratory is regulated by the Food and Drug Administration (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 Cellular Therapy (FACT).

The Cell Therapy Specialist will report to the Cell Therapy Clinical Trials Operations Manager. The primary focus of this position is towards implementation and lifecycle management of cell and gene therapy clinical trials and FDA approved products. This requires practical expertise in cell-based therapeutics in order to translate product handling in new manuals/manual updates into CTL standard operation procedures (SOPs). Furthermore, this requires close collaboration within Cell Therapeutics (CTP) including Apheresis (APH), Cell Therapy Services (CTS), and Quality Assurance (QA), as well as across departments and organizations within/outside Fred Hutchinson Cancer Center, including Principal Investigators (PI), Clinical Coordinators, corporate sponsors and vendors. This role requires strong communication skills, including facility in teaching and training staff and translating cell therapy practices clearly across functions and organizations. This role requires the ability to work independently, and identify, initiate, and execute continual process improvement initiatives for waste reduction and efficiency.

1.0 FTE Monday through Friday - 8a-5p - Onsite

Responsibilities

• Process cellular products/specimens according to standard operating procedure (SOP), and specific guidance for clinical trials, using aseptic technique.
• Perform and analyze results of quality control testing components, including automated nucleated cell counts and flow cytometry.
• Document processing steps accurately, generate processing reports and prepare patient/donor laboratory charts; review processing reports and charts.
• Understand and stay current with SOPs as needed and perform SOP qualifications. Provide input/feedback to Lab Supervisor on documentation and process improvements.
• Participate in the training process of newer, less experienced CTL Specialists.
• Develop new or non-standard procedures and processes as needed.
• Perform competency assessments as applicable.
• Thaw cryopreserved components and assist with infusion at the patient bedside.
• Meet unrelated donor (URD) component couriers and perform necessary testing and processing of components prior to release.
• Participate in implementation meetings that include but are not limited to FeasOps, Clinical Readiness, Site Initiation, Orders Validation, Patient Journey, Sponsor, workflow, etc.
• Participate in lifecycle meetings that include but are not limited to Sponsor audits, monitoring visits, regulatory inspections, etc.
• Review Sponsor-specific project source documentation and leverage technical processing experience to identify, escalate, and propose solutions to complex challenges.
• Establish clinical trial/commercial project workflows in partnership with internal and external stakeholders.
• Prepare and support mock runs in partnership with internal and external stakeholders.
• Draft and/or revise CTL SOPs to support Sponsor-specific clinical trial/commercial projects.
• Create resources for, perform, and document training of CTL staff for newly created or revised SOPs for clinical trial/commercial projects.
• Identify, escalate, and execute continuous process improvement opportunities to optimize clinical trial/commercial implementation.

Perform special processing:

• CliniMACS(r) cell selection e.g. CD34+ cell enrichment, CD3+ cell depletion
• Potentially assist with the bone marrow collection within operating room

Qualifications

Required:

• Bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution or a Bachelor's degree and equivalent education and training as defined in 42CFR493.1489(b)(3)(ii). Must meet the CLIA education requirements for a high complexity testing.
• 3+ years of experience in a clinical cell therapy laboratory with increasing responsibility.
• Basic hematology knowledge
• Motivation and initiative to learn new scientific theory and application
• Mature judgment
• Work independently
• Proven team player
• Collaborate and communicate effectively across functions
• Interpret data thoroughly
• Strong trouble-shooting capabilities
• Scientific writing skills, including preparation of clear, concise SOPs and technical reports
• Strong math skills
• Strong communication skills
• Flexibility in scheduling: nights, weekends, holidays and on-call rotations
• Must be able to differentiate between colors and pass a standardized color vision screen to perform this role

Preferred:

• At least 1 year of laboratory training or experience, or both, in high complexity testing in Flow Cytometry. Meets the CLIA training and experience requirements for a high complexity general supervisor in Flow Cytometry.
• Flow cytometry expertise
• Immunotherapy experience
• CliniMACS(r) operation experience
• LabWare, LIMS knowledge
• A good understanding of cGMP/cGTP standards

The hourly pay range for this position is from $42.65 to $63.97 and pay offered will be based on experience and qualifications.

1.0 FTE - Mon through Fri - 8a-5p - Onsite

This position may be eligible for relocation assistance.