Quality Laboratory Operations Manager

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 worlds 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 worlds 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.

• 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 FacilitiesHR 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

MINIMUM QUALIFICATIONS:

• Bachelors 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 laboratorys operations; experience with CLIA/CAP/NYS-DOH inspections; experience in assay validation writing/revising SOPs quality/compliance standards and CPI.
• Extensive Molecular laboratory skills and strong scientific knowledge in Molecular Biology and Genetics required.

PREFERRED QUALIFICATIONS:

• Demonstrates leadership skills in a laboratory setting
• Oral and written communication skills with all levels of personnel
• Complex problem-solving skills
• Demonstrated success with Process Improvement Projects
• Successful validation and implementation of new assays and instruments
• Personnel management in a CLIA/CAP/NYS-DOH environment
• Must be detailed oriented with ability to maintain accurate digital and paper records.
• Strong organizational and multi-tasking skills are required as are excellent verbal and written communication skills.
• Strong understanding of NGS and variant analysis.
• Proficiency in MS office applications/Smartsheet is highly desired.

The annual base salary range for this position is from $91333 to $136968 and pay offered will be based on experience and qualifications. This position may be eligible for relocation assistance.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health well-being and financial security. Benefits include medical/vision dental flexible spending accounts life disability retirement family life support employee assistance program onsite health clinic income-based child care subsidy tuition reimbursement paid vacation (22 days per year) paid sick leave (up to 30 calendar days per occurrence of a qualifying reason) paid holidays (13 days per year) and paid parental leave (up to 4 weeks).