Laboratory Technical Supervisor I

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.

Adaptives 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

• 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

Position Requirements (Education Experience Other)

Required

• PhD in a chemical physical biological or clinical laboratory science from an accredited institution; and at least one year 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

• Masters degree in a chemical physical biological or clinical laboratory science from an accredited institution; and at least two years 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

• Bachelors degree in a chemical physical biological or clinical laboratory science from an accredited institution; and at least four years 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: $70700- $106100

Other compensation elements to include:

• equity grant
• bonus eligible