Supervisor, Molecular Laboratory Operations

At Adaptive, we’re Powering the Age of Immune Medicine.  Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.

As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.

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Position Overview

The Area Laboratory Supervisor will be responsible for day-to-day supervision of Clinical Laboratorians in a fast-paced, high production laboratory processing research and clinical diagnostic samples. Adaptive’s Clinical Production laboratory is a CLIA/CAP/NYS/FDA certified laboratory, and as such this position needs to adhere to and uphold all applicable regulatory requirements. The Area Laboratory Supervisor will also be responsible for assisting in the daily supervision and coordinating work over a specific functional area and/or shift and works in concert with Laboratory General Supervisor of the functional area to ensure all aspects of the work are covered and ensures close communication and alignment on staff management and work.

This position reports to the Clinical Laboratory Manager, while also contributing to strategic leadership groups including Technical Supervisors, Laboratory General Supervisors, Senior Laboratory Manager, and Clinical Laboratory Directors.

Key Responsibilities and Essential Functions

Primary Responsibilities

• Obtain and/or maintain competency on Laboratory Methods, as deemed necessary by Lab Ops Management.
• Consistently demonstrate excellent clinical judgment and integrity.
• Provide day-to-day supervision of all Testing Personnel at Adaptive Biotechnology’s Production Laboratory operation:
  • Responsible for supervision of testing personnel including scheduling (e.g. frequent communication using various formats to diverse personnel, performance management, etc).
  • Facilitate orientation for new Production Laboratory employees and ensures training occurs in a timely manner.
  • Ensure all personnel are competent to perform clinical patient testing and that competency is maintained per required regulations for all procedures performed by employee.
• Responsible for the accurate and timely performance of all laboratory procedures in support of clinical and other production sample processing in Adaptive Biotechnology’s Molecular Laboratory Operations:
  • Ensure Clinical testing is performed according to documented laboratory procedures and best practices, and prioritized in order to meet or exceed TAT goals.
  • Ensure all other Production testing is completed within required timelines and per documented Work Orders, Analytical Plans or Protocols.
• Ensure that non-conformances are appropriately documented and escalated to the Clinical Laboratory Director or their designee, and that appropriate remedial actions occur in order to maintain acceptable levels of analytic performance, and ensure that accurate patient test results are being generated.
• Regulatory responsibilities per Good Manufacturing Practices (GMP)
• Regulatory responsibilities per Good Clinical Practices (GCP)
• Regulatory responsibilities per 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

Core Competencies 

• Create, maintain and modify laboratory schedule; plan for and manage time for self and team to ensure tasks and deadlines are met.
• Understand all workflows within the laboratory, as well as exhibit familiarity with processes that impact Production Laboratory workflows.
• Offer recommendations to improve processes and assists with implementing new methods or process improvement.
• Exhibit sound understanding of both biological processes involved in assays, as well as technical instructions for processing samples (i.e. LIMS, instrumentation, robotics, etc) underlying procedures in assigned work area (e.g. Sample Prep, PCR, Sequencing, etc).
• Demonstrate ability to identify when a Nonconformance, Deviation or CA/PA is necessary, and appropriately escalate issues that could impact quality or result in delay of patient testing/test results.
• Anticipate and prevent errors from occurring; assist in pinpointing root causes of errors and identifying solutions
• Stand behind decisions and take accountability for decisions.
• Provide clear and effective communication to Production Laboratory emp