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 RD, 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. Collaborate with Engineering, Bioinformatics, Accessioning, and Operations teams to define key operational metrics and support LIMS implementation. Proactively identify operational risks and implement mitigation strategies. Operations Establish and monitor operational KPIs including throughput, productivity, error rates, and process efficiency, and use data to drive continuous improvement. Oversee daily laboratory operations to meet TAT, SLA, quality, and cost objectives. Ensure compliance with CLIA, CAP, and applicable state regulatory requirements, and maintain inspection readiness. Lead continuous improvement initiatives to optimize workflow and automation. Serve as escalation point for technical and operational issues. Lead investigations of laboratory deviations and nonconformances, ensuring timely CAPA initiation, root cause analysis, and closure. Oversee quality control programs and proficiency testing to ensure continued assay performance and regulatory compliance. Identify equipment, supply, and infrastructure needs required to support laboratory operations and scale. Drive continuous improvement initiatives to enhance laboratory efficiency, scalability, and quality. Performs other duties as assigned. QUALIFICATIONS Required Bachelor’s degree in Biological Sciences or related field. Current California Clinical Laboratory Scientist (CLS) license or CGMBS license. 5+ years of experience in a high-complexity clinical laboratory. 3+ yea ... (truncated, view full listing at source)