Principal, NGS Laboratory Implementation & Operations

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Position Overview

The Principal NGS Laboratory Implementation & Operations is responsible for ensuring operational readiness and successful implementation of NGS assays within the commercial laboratory environment. This role is embedded within Laboratory Operations and focuses on translating development outputs into scalable reliable and production-ready laboratory processes.

This individual represents the Laboratory Operations perspective across cross-functional programs to ensure assays workflows and technologies are deployable within a clinical production setting. The role emphasizes execution consistency and alignment of operational requirements during transition from development into the laboratory.

This role partners closely with R&D laboratory operations quality and program leadership to enable efficient standardized deployment of NGS workflows and support successful scale-up in the commercial laboratory.

Essential Duties

Include but are not limited to the following:

• Represent Laboratory Operations to define operational requirements and ensure NGS assays are designed for successful commercial implementation including workflow compatibility with throughput automation staffing cost and infrastructure constraints.
• Lead the transition of assays from development into clinical laboratory workflows partnering with R&D and program teams to translate development outputs into scalable production-ready processes.
• Collaborate with laboratory operations leadership to define and drive integration of new assays into existing systems workflows and processes ensuring alignment on timelines requirements and deployment readiness criteria.
• Drive assay deployment and scale-up by identifying operational gaps capacity constraints risks and process inefficiencies and implementing solutions to ensure successful execution.
• Provide operational oversight during early production to ensure assay performance stability and adherence to quality standards.
• Drive continuous improvement by systematically incorporating operational learnings into future assay deployments.
• Ensure implementation and scale-up activities comply with applicable regulatory and quality requirements (e.g. CAP/CLIA) proactively addressing compliance risks.
• Serve as a subject matter resource on NGS deployment and laboratory integration best practices guiding cross-functional teams and influencing implementation strategy.
• Support and comply with the companys Quality Management System policies and procedures.

Minimum Qualifications

• Bachelors Degree in a field related to essential duties; or Associates Degree and 2 years of relevant experience; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience.
• 12 years of experience in molecular diagnostics NGS or clinical laboratory operations within regulated environments (e.g. CAP/CLIA).
• Demonstrated experience operationalizing and scaling assays from development into clinical or commercial laboratory settings including strong knowledge of NGS workflows.
• Proven ability to lead cross-functional initiatives and deliver complex projects in a fast-paced environment.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Ability to travel up to 10% as needed.
• Ability to comply with laboratory safety and PPE requirements.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Bachelors degree in Biology Chemistry Engineering or a related field.
• Advanced degree (Masters or Ph.D.) in a relevant scientific or engineering field.
• Direct experience with large-scale NGS assay deployment and commercialization.
• Experience with process improvement methodologies and workflow optimization (e.g. Lean Six Sigma).

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

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