Manager, Clinical Laboratory, ECD

POSITION SUMMARY

The Manager, Clinical Laboratory is a foundational leader responsible for initiating and scaling a new CLIA high-complexity laboratory performing an FDA-approved early cancer detection test for colorectal cancer screening. Under the direction of senior laboratory leadership, and in close collaboration with cross-functional partners, this individual provides operational and strategic leadership for the colorectal cancer screening assay within the clinical laboratory.

 

As the first operational hire, this individual will establish the technical, operational, and cultural foundation of the laboratory. The role will initially focus on lab set-up, SOP development, and hiring of Clinical Laboratory Scientists (CLS) and Clinical Laboratory Associates (CLA), then transition to training and large-scale, high-throughput assay validation. In partnership with R&D, Quality, Regulatory, and Engineering teams, this leader will ensure compliant, scalable implementation of the assay.

 

As volume increases, the Manager will assume full operational ownership of a high-throughput clinical laboratory, accountable for quality, turnaround time, staffing strategy, regulatory compliance, and team performance.

 

This role requires a high-energy, deeply accountable self-starter who combines strong technical expertise with exceptional organizational and leadership skills.

 

PRIMARY RESPONSIBILITIES

Team Leadership

• Recruit, hire, train, and develop a high-performing CLS and CLA team.

• Develop high-performing employees through training, cross-training, and growth opportunities.

• Implement competency assessments and performance management processes. Ensure training documentation and competency records are maintained in compliance with regulatory requirements.

• Build a culture of accountability, urgency, and operational excellence.

• Conduct performance reviews and develop future supervisors and leads.

• Plan staffing levels and scheduling to ensure laboratory capacity meets testing demand and turnaround time commitments.

 

Laboratory Build & Validation

• Develop and maintain SOPs, work instructions, training programs, and controlled documentation.

• Execute assay verification and validation studies in compliance with CLIA high-complexity requirements (in close partnership with Bio Development)

• Ensure CLIA & FDA inspection readiness and audit preparedness (in close partnership with Quality and Regulatory)

 

Cross-Functional Partnership

• Partner closely with BioDev on usability of assay workflows. 

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