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. 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+ years of leadership experience. Experience executing assay validation in a regulated clinical environment. Strong knowledge of CLIA and CAP requirements. Preferred Experience with molecular or oncology-based assays. Experience scaling high-throughput laboratory operations. Lean/Six Sigma or process improvement experience. Experience supporting tech transfer from R&D to operations. KNOWLEDGE, SKILLS, AND ABILITIES Operates effectively at both strategic and tactical levels. Highly organized with exceptional attention to detail. Strong analytical and problem-solving skills. Proven ability to build and lead engaged, high-performing teams. Clear communicator across technical and non-technical audiences. Demonstrates deep ownership, accountability, and patient-focused decision-making. PHYSICAL DEMANDS & WORK ENVIRONMENT Duties are performed in a clinical laboratory environment. This position requires the ability to work on a computer, operate laboratory equipment, and occasionally lift laboratory supplies. Standing or sitting for extended periods may be required. Evening or weekend work may occasionally be required to support laboratory operations. WHY THIS ROLE This is a rare opportunity to build and lead a high-complexity clinical laboratory from the ground up in support of a mission-critical, FDA-approved cancer screening test. The Manager will directly shape operational excellence, team culture, and long-term scalability of a program designed to impact patient care at scale. Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including: Annual performance incentive bonus Long-term equity awards Comprehensive health benefits (medical, dental, vision) 401(k) with company match Generous paid time off and company holidays Additional wellness and work-life benefits Compensation Range $111,500 — $139,400 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com . Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page