Supervisor, Clinical Laboratory Operations Area

Key Responsibilities and Essential Functions

• Utilize technical molecular biology knowledge (DNA extraction, PCR, qPCR, and/or next-generation DNA sequencing) to coordinate high-quality processing of specimens through the laboratory.
• Consistently demonstrate excellent clinical judgment and integrity.
• Effectively and timely communicate and collaborate across teams, departments, and disciplines to meet objectives.
• Understand when to solve problems independently or escalate them with management.
• Provide day-to-day supervision of lab personnel at Adaptive Biotechnology's Clinical Laboratory Operation: Responsibilities may include scheduling/task assignment within a lab area and monitoring of area team effectiveness and efficiency.
• Utilize frequent and varied communication across diverse personnel for performance management.
• Facilitate orientation for new personnel within a lab area and ensure training occurs in a timely manner.
• Ensure all personnel are competent to perform clinical patient testing and competency is maintained per required regulations for all procedures performed by employee.
• Ensure that continuing education requirements are met.
• Ensure EHS policies and procedures are being followed and opportunities for improvements are escalated to EHS and management.
• Monitors and ensures that acceptable test performance specifications are maintained through monitoring instrument and equipment maintenance and availability.
• Resolving technical problems in accordance with policies and procedures.
• As applicable, reviewing quality measures throughout the testing process to ensure accurate and reliable results.
• Accountable for the timely delivery of Incident and Non-Conformance investigation Triage, review and approve incident and non-conformance records.
• Ensure records are complete by working with the appropriate quality teams and providing feedback to the investigator.
• Ensure that incidents and non-conformances are appropriately documented, when necessary escalated to the Clinical Laboratory Director or their designee, and that appropriate remedial actions occur.
• Assists with the timely delivery of project deliverables in support of Adaptive company goals.
• May assist with SOP/MET revision content.
• May assist with delegating tasks to meet scheduled deadlines.
• Regulatory responsibilities per Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
• Regulatory responsibilities of "Testing Personnel" for high complexity testing as defined by 42CFR493.1495.
• Regulatory responsibilities of "General Supervisor" for high complexity testing as defined by 42CFR493.1463.

Position Requirements (Education, Experience, Other)

Required: Earned BS degree in a Chemical, Physical or Biological Science from an accredited institution, with greater than four years of pertinent molecular laboratory experience subsequent to qualifying of which at least one years have been spent working in a clinical laboratory meeting the definition of high-complexity. OR Earned MS degree with a major in Chemical, Physical or Biological Science from an accredited institution with greater than two years of pertinent molecular laboratory experience of which at least one year has been spent working in a clinical laboratory meeting the definition of high complexity.

Technical background in molecular biology (e.g. DNA Extraction, PCR, qPCR, next-generation DNA sequencing), laboratory automation, and laboratory best practices.

Self-motivated and can work independently, with minimal supervision, while also managing a highly complex team in a dynamic organization.

Ability to think critically and creatively about processes and procedures.

Preferred: 2+ years working at Adaptive in the Clinical laboratory. Some team or shift lead experience that includes personnel management and laboratory process improvements. ASCP(MB) certification.

Working Conditions

The job involves working in a laboratory handling human biological specimens, chemical and biohazardous materials. Flexibility and willingness to work more than standard hours when necessary, including nights, weekends & holidays. Schedule: Wednesday - Saturday 9:30am - 8:00pm.

Physical Requirements

Individuals are required to sit or stand for much of the workday and perform tasks on computer systems.