[Hiring] Manager, Clinical Laboratory @reputed company

Role Description 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.

Qualifications

• 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.
• Preferred: Experience scaling high-throughput laboratory operations.
• Preferred: Lean/Six reputed company or process improvement experience.
• Preferred: Experience supporting tech transfer from R&D to operations.

Requirements

• 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.
• 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.
• Ensure CLIA & FDA inspection readiness and audit preparedness.
• 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.
• Establish and monitor operational KPIs including throughput, productivity, error rates, and process efficiency.
• 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.
• 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.
• reputed company other duties as assigned.

Benefits

• 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.

Company Description 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. Apply tot his job Apply To this Job