Senior Manager, Operational Excellence and Process Engineering

About the role

The Senior Manager, Laboratory Systems & Process Engineering owns the end-to-end implementation and optimization of laboratory systems and operational processes for Foresight Diagnostics, a Natera business unit. This role directly manages a team of Laboratory Systems Scientists and serves as a critical operational leader within the Operational Excellence and Process Engineering organization. The Senior Manager bridges strategic direction from laboratory operations leadership with day-to-day execution across laboratory systems, process engineering, asset management, and technology transfer initiatives. They ensure laboratory systems and workflows are scalable, efficient, compliant, and aligned with organizational growth and business objectives. This position requires strong leadership and the ability to exercise independent judgment in managing complex cross-functional initiatives in a regulated clinical laboratory environment. The Senior Manager partners closely with Laboratory Operations, R&D, Bioinformatics, Software Engineering, Automation Engineering, Quality, Regulatory, and Product teams to operationalize new capabilities.

Key facts

What you'll 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 to foster a high-performance, engaged team environment.

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 with a focus on quality and timeliness.

Partner cross-functionally to ensure successful technology transfer, user adoption, training, and operational readiness for new laboratory capabilities and systems.

Apply Lean principles and process engineering methodologies to improve operational efficiency, workflow reliability, throughput, and scalability in clinical laboratory operations.

Identify process bottlenecks, operational risk, and system inefficiencies through analysis of operational and analytical performance metrics and data.

Lead structured problem-solving and root cause investigations to resolve complex operational issues and implement sustainable corrective and preventive 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 adhere to current good manufacturing practices (cGMP), standard operating procedures (SOPs), and regulatory requirements.

Drive continuous improvement initiatives to enhance laboratory performance, quality, and compliance across all facets of laboratory operations and system execution.

Collaborate with Quality and Regulatory teams to ensure all laboratory systems, processes, and changes maintain compliance and support audit readiness.

Act as a subject matter expert and primary point of contact for laboratory systems and process engineering initiatives with internal stakeholders and external partners.

Requirements

Bachelor's degree in a relevant scientific or engineering discipline required; advanced degree preferred.

Minimum of 8 years of relevant experience in molecular diagnostics, biotechnology, or a related life sciences industry environment.

Minimum of 5 years of experience in a leadership or management role overseeing scientists or technical professionals.

Demonstrated experience in laboratory systems implementation, process engineering, and validation within a regulated clinical laboratory setting.

Strong understanding of molecular diagnostics technologies, laboratory workflows, and Good Manufacturing Practices (cGMP) principles.

Proven track record of applying Lean Six Sigma or similar process improvement methodologies to drive operational excellence.

Excellent knowledge of laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), and other core laboratory software systems.

Exceptional leadership, communication, and interpersonal skills necessary to manage, develop, and influence cross-functional teams.

Nice to have

Previous experience in a high-complexity clinical laboratory environment.

Experience with automation platforms and robotics in a laboratory setting.

Knowledge of bioinformatics data pipelines and NGS technologies.

Experience supporting technology transfer and clinical partnerships.

Practical notes

This role is based in Boulder, Colorado and requires on-site presence.

Full-time position; standard work hours apply.

Travel may be required as needed for business purposes.

Employment is contingent on successful completion of background checks and verification of credentials.