Senior Lab Systems & Process Excellence Manager

Natera; Boulder (CO); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical benefits

Fertility care benefits

401k & commuter benefits

Employee referral program

Job summary

Natera is a global leader in cfDNA testing, delivering oncology, women’s health, and organ health solutions. The Senior Manager will lead a team of Laboratory Systems Scientists, drive system implementation and process engineering across the lab, and partner with stakeholders to enable scalable, compliant operations.

The role emphasizes Lean processes, data-driven improvements, and regulatory readiness, with responsibilities spanning validation, tech transfer, and cross-functional collaboration

Qualifications

• Bachelor's degree in Life Sciences, Engineering, CS, or related field.
• 8+ years of laboratory experience in diagnostics or life sciences.
• 4+ years of people management in technical/operational teams.
• 3+ years in regulated lab environments (CAP/CLIA/NYSDOH/GxP/ISO).
• Expertise in laboratory systems, automation, or software integration.
• Experience with NGS or complex molecular workflows.
• Proven PQ/verification/validation experience under regulatory standards.
• Knowledge of LIMS and digital workflow tools.
• Strong cross-functional collaboration and communication.

Responsibilities

• Directly manage and develop a team of Laboratory Systems Scientists responsible for laboratory systems implementation, process engineering, validation activities, and operational support.
• Provide coaching, mentorship, performance management, and career development to team members.
• Establish team priorities, allocate resources, and ensure successful execution of operational and strategic initiatives under the direction of the Director of Laboratory Operations.
• Lead implementation and optimization of laboratory systems including automation platforms, laboratory software solutions, assay chemistry changes, laboratory workflows, and operational infrastructure.
• Support operational rollout of new assays, platforms, workflows, software solutions and clinical partnerships into the clinical production environments.
• Partner cross-functionally to ensure successful technology transfer, user adoption, training, and operational readiness.
• Apply Lean principles and process engineering methodologies to improve operational efficiency, workflow reliability, throughput, and scalability.
• Identify process bottlenecks, operational risk, and system inefficiencies through analysis of operational and analytical performance data.
• Lead structured problem-solving and root cause investigations to resolve complex operational issues and implement sustainable corrective actions.
• Oversee execution of validation, verification, and performance qualification activities for laboratory systems, automation platforms, instrumentation/equipment, and operational workflows as assigned.
• Ensure laboratory systems and operational processes align with CAP, CLIA, NYSDOH, GxP and applicable regulatory requirements.
• Collaborate with cross functional stakeholders to define system requirements and operational priorities translating operational needs into functional requirements and scalable process solutions.
• Support development and monitoring of KPIs, dashboards, and operational metrics related to laboratory systems, workflow performance, quality, and throughput as assigned utilizing operational data to identify trends, evaluate system effectiveness, and drive data-informed process improvements.
• Support change control activities and ensure proper documentation of operational and system modifications.
• Serve as a senior operational and technical resource for laboratory systems and process engineering initiatives.
• As required, participate in internal and external audits.
• Other duties as assigned.

Skills

Laboratory systems

Process engineering

People management

Regulatory compliance

Lean methodology

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related

Advanced degree (MS/PhD) preferred

Tools

LIMS

Lab automation software

Workflow software

Job description

Natera is a global leader in cfDNA testing, delivering oncology, women’s health, and organ health solutions. The Senior Manager will lead a team of Laboratory Systems Scientists, drive system implementation and process engineering across the lab, and partner with stakeholders to enable scalable, compliant operations.

The role emphasizes Lean processes, data-driven improvements, and regulatory readiness, with responsibilities spanning validation, tech transfer, and cross-functional collaboration