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Team Leadership:
- Recruit, hire, train, and develop a high-performing CLS and CLA team.
- Implement competency assessments and performance management processes.
- Build a culture of accountability, urgency, and operational excellence.
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.
- Ensure CLIA & FDA inspection readiness and audit preparedness.
Operations:
- Establish and monitor operational KPIs including throughput, productivity, error rates, and process efficiency.
- Oversee daily laboratory operations to meet TAT, SLA, quality, and cost objectives.
- Lead investigations of laboratory deviations and nonconformances, ensuring timely CAPA initiation, root cause analysis, and closure.
Natera
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health, aiming to make personalized genetic testing and diagnostics part of the standard of care. The Natera team consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions.