Senior Manager, Operational Excellence and Process Engineering

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. This role serves as a critical operational leader within the Operational Excellence and Process Engineering organization, bridging strategic direction from laboratory operations leadership with day-to-day execution across laboratory systems, process engineering, asset management, and technology transfer initiatives. The Senior Manager is responsible for ensuring laboratory systems and workflows are scalable, efficient, compliance, and aligned with organizational growth and business-aligned objectives. The Senior Manager partners closely with Laboratory Operations, R&D, Bioinformatics, Software Engineering, Automation Engineering, Quality, Regulatory, and Product teams to operationalize new capabilities, improve laboratory performance, and support high-throughput and high-complexity molecular testing operations. This position requires strong leadership, operational, and process engineering capabilities, along with the ability to exercise independent judgment in managing complex cross-functional initiatives and operational challenges in a regulated clinical laboratory environment. This position reports to the Director of Laboratory Operations.

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

Requirements

Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field required; 8+ years of relevant laboratory experience in diagnostics, life sciences, or related field; 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; Strong leadership, operational, and process engineering capabilities; Ability to exercise independent judgment in managing complex cross-functional initiatives and operational challenges in a regulated clinical laboratory environment

Nice to have

Advanced degree

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; Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents; Free testing for employees and their immediate families; Fertility care benefits; Pregnancy and baby bonding leave; 401k benefits; Commuter benefits; Employee referral program