Senior Manager, Operational Excellence and Process Engineering

Natera

Boulder (CO)

On-site

USD 140,000 - 190,000

Full time

14 days+

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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

About The Role

The Senior Manager, Laboratory Systems & Process Engineering is a people and technical leadership role responsible for managing a team of Laboratory Systems Scientists while driving the implementation, optimization, and continuous improvement of laboratory systems and operational processes supporting Foresight Diagnostics’ laboratory operations.

Location: Boulder, CO

What You Will Do

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.

What You Will Bring

Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field required; advanced degree preferred.
8+ years of relevant laboratory experience in diagnostics, life sciences, or related field; advanced degree preferred.
4+ years of direct people management experience leading technical or operational teams.
3+ years of experience in regulated laboratory environments (CAP, CLIA, NYSDOH, GxP, or ISO 13485/15189).
Strong expertise in laboratory systems, automation, or software integration, with demonstrated success leading cross-functional system implementation or process optimization projects.
Significant experience in NGS or other complex molecular workflows with deep understanding of process development and validation.
Proven ability to lead, design, execute, and document PQ, verification, and validation studies in compliance with regulatory requirements.
Strong understanding of developing LIMS, digital workflow tools, equipment management systems, and laboratory informatics platforms.
Expertise in systems thinking and strategic problem-solving skills, able to anticipate downstream impacts and propose scalable solutions.
Excellent cross-functional collaboration skills with ability to balance scientific, technical, and business requirements.
Experience supporting or leading tech transfer and process scaling initiatives in a dynamic laboratory setting.
Strong written and verbal communication skills with ability to draft technical reports, SOPs, and training documentation.
Demonstrated ability to manage multiple operational initiatives concurrently.
Proven ability to operate effectively in fast-paced, high-growth organizations and with supporting teams through significant organizational change.
A flexible, self-starter mindset with the ability to manage multiple priorities in a fast-paced startup environment.

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: https://www.natera.com/notice-of-data-collection-california-residents/

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.

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