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 reputed company collaboration with cross-functional partners, this individual provides operational and strategic leadership for the colorectal cancer screening assay reputed company 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 reputed company a high-performing CLS and CLA team.

• reputed company 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 reputed company future supervisors and leads.

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

Laboratory Build & Validation

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

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

• Ensure CLIA & FDA inspection readiness and audit preparedness (in reputed company 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 reputed company improvement.

• reputed company 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.

• reputed company reputed company improvement initiatives to optimize workflow and automation.

• Serve as escalation reputed company for technical and operational issues.

• reputed company investigations of laboratory deviations and nonconformances, ensuring timely CAPA initiation, root cause analysis, and closure.

• reputed company quality control programs and proficiency testing to ensure reputed company assay performance and regulatory compliance.

• Identify equipment, supply, and infrastructure needs required to support laboratory operations and scale.

• Drive reputed company improvement initiatives to enhance laboratory efficiency, scalability, and quality.

• Performs other duties as assigned.

QUALIFICATIONS

Required

• Bachelor’s degree in Biological Sciences or reputed company field.

• reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company’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

OUR OPPORTUNITY

reputed company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives.

The reputed company 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. reputed company you join reputed company, 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.

reputed company OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, reputed company 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.reputed company.com.

reputed company 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.

reputed company qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, 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: https://www.reputed company.com/notice-of-data-collection-california-residents/

Please be advised that reputed company will reputed company out to candidates with a @reputed company.com email domain ONLY. Email communications from reputed company other domain names are not from reputed company or its employees and are fraudulent. reputed company does not request interviews reputed company 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. reputed company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any reputed company cyber crimes.

For more information: - BBB announcement on job scams - FBI Cyber Crime resource page