Laboratory Technical Supervisor I/II/Senior

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Position Overview

Provide technical functions and support for CLIA/CAP regulated high complexity clinical laboratory performing molecular testing using NGS; and assist with maintenance of laboratory compliance.

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.

Key Responsibilities and Essential Functions - Laboratory Technical Supervisor I

• Trains on and will achieve competency on the review of flowcell and sample data QC  for trials and research studies, and first review of patient flowcell and sample data QC (for subsequent review and approval by an individual qualified as a Clinical Laboratory Director)
• Assists with providing technical troubleshooting to the clinical lab and to related quality improvement initiatives
• Monitors and trends quality metrics and assists with preparing weekly, monthly and quarterly reports for review and approval by a Clinical Laboratory Director, as appropriate
• Reviews and/or edits laboratory requirement documents (e.g., Analytic Methods, SOPs, IQOQPQ reports) for approval by a Clinical Laboratory Director
• Reviews maintenance reports for completeness and accurate documentation
• May assist with special projects such as LIMS Development in collaboration with the software team (e.g., creates dashboards for tracking and prioritizing requests, generates user requirements, UAT cases and plans, completes test plans, and related documents for system features and enhancements) under supervision of a more senior Technical Supervisor or Manager
• Alerts a Clinical Laboratory Director in a timely manner of quality, technical, or operational readiness issues that could impact patient testing and ensures all clinical laboratory teams comply with applicable regulations, e.g. non-conformances and/or incidents
• Collaborates with lab management and/or Clinical Laboratory Directors to develop and continuously improve day-to-day operations and ensure cross-functional alignment with laboratory support groups
• Assists more senior Laboratory Technical Supervisors with presentations for cross functional teams
• Reviews and approves training and competency assessments for CLO, as appropriate
• Collaborates with Operational Software Support on resolving issues such as sample re-directs, SKU switches, Portal requeues, and sample sheet issues
• Promotes a patient-centric culture where every patient result matters, and champions alignment with company goals and values
• Note that all responsibilities are to be defined to align with the definition of a Technical Supervisor under CLIA and NYS CLEP. All functions of a Technical Supervisor under CAP require oversight by a Clinical Laboratory Director.
• Follow Good Clinical Laboratory Practices (GCLP)
• Regulatory responsibilities of “Testing Personnel” for high complexity testing as defined by 42CFR493.1495 and NYCRR Title 10 Section 58-1.5(a)
• Regulatory responsibilities of “General Supervisor” for high complexity testing as defined by 42CFR493.1463 and of "Supervisor" as defined by NYCRR Title 10 Section 58-1.3
• CAP responsibilities of "Molecular Pathology General Supervisor" as defined by requirement GEN.53600
• Regulatory responsibilities (when delegated) of “Technical Supervisor” for high complexity testing as defined by 42CFR493.1451
• CAP responsibilities (when delegated) of "Molecular Pathology Technical Supervisor" as defined by GEN.53400
• All other duties as assigned

Key Responsibilities and Essential Functions - Sr Laboratory Technical Supervisor

• Applies deep subject matter expertise in molecular laboratory technical applications in order to propose solutions to complex problems thereby supporting the clinical laboratory needs for throughput, and to promote accurate result generation while keeping specified lab TAT in mind
• Provides review of flowcell and sample data QC for trials and research studies, and first review of patient flowcell and sample data QC  (for subsequent review and approval by an individual qualified as a Clinical Laboratory Director)
• Represents the clinical laboratory technical operations function on core teams and an expert at providing technical troubleshooting to the clinical lab and to related quality improvement initiatives
• Develops new metrics and/or tools to monitor and trend quality metrics and prepares/oversees weekly, monthly, and quarterly reports for review and approval by a Clinical Laboratory Director, as appropriate
• Authors and/or reviews laboratory requirement documents (e.g., Analytic Methods, SOPs, IQOQPQ reports) for approval by a Clinical Laboratory Director
• Reviews maintenance reports for completeness and accurate documentation
• Supports LIMS Development in collaboration with the software team (e.g., creates dashboards for tracking and prioritizing requests, generates user requirements, UAT cases and plans, completes test plans, and related documents for system features and enhancements)
• Assigns and monitors timely, accurate completion of proficiency testing for review and approval by the Clinical Laboratory Director
• Alerts a Clinical Laboratory Director in a timely manner of quality, technical, or operational readiness issues that could impact patient testing and ensures all clinical laboratory teams comply with applicable regulations e.g. non-conformances and/or incidents
• Collaborates with lab management and/or Clinical Laboratory Directors to develop and continuously improve day-to-day operations and ensure cross-functional alignment with laboratory support groups
• Responsible for organizing data and collaboration for cross functional presentations
• Reviews and approves training and competency assessments for CLO, as appropriate
• Collaborates with Operational Software Support on resolving issues such as sample re-directs, SKU switches, portal requeues, and sample sheet issues
• Assigns and monitors timely, accurate completion of proficiency testing for review and approval by the Clinical Laboratory Director
• Responsible for onboarding and training new Technical Supervisors in flowcell and sample data QC as well as all Technical Supervisor duties
• Participates in CAP self-inspections as well as on-site CAP inspections
• Designated as a technical SME for external audits
• Promotes a patient-centric culture where every patient result matters, and champions alignment with company goals and values
• Note that all responsibilities are to be defined to align with the definition of a Technical Supervisor under CLIA and NYS CLEP. All functions of a Technical Supervisor under CAP require oversight by a Clinical Laboratory Director.
• Ability to follow Good Clinical Laboratory Practices (GCLP)
• Regulatory responsibilities of “Testing Personnel” for high complexity testing as defined by 42CFR493.1495 and NYCRR Title 10 Section 58-1.5(a)
• Regulatory responsibilities of “General Supervisor” for high complexity testing as defined by 42CFR493.1463 and of "Supervisor" as defined by NYCRR Title 10 Section 58-1.3
• CAP responsibilities of "Molecular Pathology General Supervisor" as defined by requirement GEN.53600
• Regulatory responsibilities (when delegated) of “Technical Supervisor” for high complexity testing as defined by 42CFR493.1451
• CAP responsibilities (when delegated) of "Molecular Pathology Technical Supervisor" as defined by GEN.53400
• All other duties as assigned

Position Requirements (Education, Experience, Other)

Required

• PhD in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least 1 year (3 years for Senior level) of laboratory training or experience from an accredited laboratory in high complexity clinical molecular pathology/genetics testing under the direct or indirect supervision of a board-certified Clinical Laboratory Director

OR

• Master’s degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least 2 years (6 years for Senior level) of laboratory training or experience from an accredited laboratory in high complexity clinical molecular pathology/genetics testing under the direct or indirect supervision of a board-certified Clinical Laboratory Director

OR

• Bachelor’s degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and at least 4 years (8 years for Senior level) of laboratory training or experience from an accredited laboratory in high complexity testing under the direct or indirect supervision of a board-certified Clinical Laboratory Director (at least two of which are in clinical molecular pathology/genetics methods under a qualified Clinical Laboratory Director)

PLUS

• Specialized knowledge, experience, and skills in related fields: Molecular biology techniques (DNA extraction, PCR, Next-generation sequencing [NGS]), laboratory automation, Laboratory information management systems, reagent and instrument qualification, Clinical patient care, NGS data analysis, CAP/CLIA/NYCLEP/IVD/GxP regulations
• Strong communication and interpersonal skills
• Advanced critical thinking and problem-solving skills
• Ability to work in a team environment
• Promotes a positive work environment while supporting management and business goals
• Ability to collaborate across teams and disciplines
• Creates a productive and professional culture
• Upholds clinical laboratory best practices; and complies with applicable regulations

Preferred experience, skills, and qualifications

• Experience reviewing Illumina sequencer analytics
• Experience within regulated GxP laboratory environment

Working Conditions

May require entrance to the clinical laboratory and working with patient samples and lab automation equipment. Hybrid work conditions preferred, open to remote (WFH). If WFH, must have high speed internet connection suitable for sustained video conferencing.

Physical Requirements

Prolonged periods of working at a computer. May include some time shadowing laboratory staff or working in the laboratory.

#LI-Remote

Compensation

Salary Range: 

• Laboratory Technical Supervisor I: $70,700 - $106,100
• Laboratory Technical Supervisor II: $89,100 - $133,700
• Sr Laboratory Technical Supervisor: $100,600 - $150,800

Other compensation elements include:

• equity grant
• bonus eligible

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Interested in this position, but don’t meet all the requirements?  Adaptive is committed to building diverse, equitable, and inclusive teams across our organization.  Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!

Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.

Adaptive's benefits at-a-glance.

Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the Equal Employment Opportunity Posters for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@adaptivebiotech.com.

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