Quality Laboratory Operations Manager

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 Laboratory Operations Manager oversees general operations of the Molecular Oncology lab, which performs molecular tests related to diagnosis, treatment and post-treatment follow-up of disease. This role provides direction and support for clinical lab staff, and ensures all clinical activities adhere to CLIA, CAP, NYS-DOH, FDA, and GLP/GCP regulatory guidelines. This position is also responsible for overseeing the planning, coordination, implementation, and improvement of processes and systems , as well as operational expansions. This role requires routine weekend work, with a Tuesday -Saturday schedule with some flexibility.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• Responsible for managing and maintaining Molecular Oncology laboratory operations, including staff scheduling, data analysis, reporting, billing, hiring, training and competencies, equipment, reagents, and other relevant areas of the clinical lab.
• Primary point of contact for all operational inquiries, both internal and external.
• Works with lab supervisor to troubleshoot pre-analytical, analytical, and post-analytical errors, escalating to the Lab Director when appropriate. (primary responsibility for this will now be QLS)
• Site coordinator for MyeloMATCH and other clinical trials. Responsible for communications with and management of inquiries received by sponsor and FDA consultant.
• Collaborates with the Medical Director, Quality Systems Manager, and Clinical Supervisors to develop laboratory policies, systems, standard operating procedures and study-specific protocols for laboratory operations, ensuring compliance with quality, regulatory and other applicable guidelines to maintain CLIA/CAP/NYS-DOH/FDA regulatory licensures for Fred Hutch
• Participates in short- and long-term planning of laboratory operations including anticipation of staff, equipment and space needs, financial goals, and capacity planning.
• Provides forecasting data regarding supplies and staffing during grant budgeting reviews.
• Works collaboratively with various internal and external departments (including EH&S, Facilities,HR, IT) to ensure operational success of the CLIA laboratories and related activities.
• Manages development, validation, and implementation of new assays and instrumentation.
• Other duties as assigned.
• Works with lab administration to oversee operational budget, including:
  • Performing cost analyses as needed.
  • Interactions with contractors re: staffing/personel accounting
  • Clinical billing/revenues

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in the field of Laboratory Science, Medical Technology, Biological Science, or equivalent.
• Minimum 4 years lab management experience.
• Minimum 4 years experience as a licensed technologist performing molecular pathology methods that qualify as high complexity testing, with progressively increasing responsibilities.
• Certified by the American Society of Clinical Pathologists (ASCP) as a Medical Laboratory Scientist (MLS) or Molecular Biologist (MB), or equivalent.
• Thorough understanding of regulations applicable to a CLIA laboratory’s operations; experience with CLIA/CAP/NYS-DOH inspections; experience in assay valid