Laboratory Supervisor, Lab Management

Thermo Fisher Scientific•West Sacramento, CA

8d•$83,300 - $125,000•Onsite

About The Position

As a Laboratory Supervisor within the Lab Management team, you will lead the people and operational processes that enable efficient, compliant and reliable testing in a clinical trials laboratory supporting next-generation sequencing (NGS). You will oversee Receiving & Accessioning, Materials Management & Inventory, and Equipment Management, Cold Storage & Capacity Planning. Receiving & Accessioning is a key focus of this role. The successful candidate will bring strong experience in specimen receipt, accessioning, sample documentation, issue resolution and pre-analytical workflows in a regulated laboratory environment. You will ensure samples are received, documented, accessioned and routed accurately and efficiently while maintaining sample integrity, traceability and compliance. This is a people manager role responsible for developing a high-performing team, managing daily workload and staffing, monitoring performance, and driving continuous improvement. You will partner across Laboratory Operations, Quality, Supply Chain, Project Management, Information Technology, Facilities and other functions to ensure the laboratory has the samples, materials, equipment, cold storage and capacity required to meet clinical trial commitments.

Requirements

Bachelor's degree in Molecular Biology, Biochemistry, Genetics, Medical Laboratory Science, Biological Sciences or a related scientific discipline required
3+ years of laboratory operations experience required
Direct experience in specimen receiving, accessioning, sample processing, or pre-analytical laboratory operations strongly preferred.
Demonstrated knowledge of accessioning workflows, specimen handling requirements, sample traceability, documentation and resolution of specimen discrepancies required.
Previous experience supervising or leading employees required
Direct people-management experience in a clinical or regulated laboratory environment strongly preferred.
Experience in a clinical laboratory, clinical trials laboratory, diagnostic laboratory or other regulated laboratory environment preferred.
Experience with high-volume or time-sensitive laboratory operations and LIMS/LIS or electronic sample tracking strongly preferred.
Experience with laboratory inventory/materials management, equipment management and temperature-controlled storage operations preferred.
Experience working within a QMS and knowledge of CAP, CLIA, GDP, OSHA and other applicable regulatory requirements preferred.
Strong knowledge of receiving and accessioning operations, including specimen receipt, reconciliation, accessioning, documentation, traceability, sample routing and exception management.
Strong people leadership skills with the ability to coach, develop, engage and hold teams accountable.
Ability to manage multiple operational workstreams while maintaining focus on quality, accuracy, turnaround time and customer commitments.
Strong problem-solving and critical-thinking skills with the ability to troubleshoot sample, system, equipment and workflow issues.
Ability to use operational metrics and data to evaluate performance, identify constraints and make informed staffing and capacity decisions.
Excellent organizational, prioritization, written and verbal communication skills.
Ability to collaborate effectively across laboratory, technical, quality and business functions and with external service providers.
Proficiency with Microsoft Office applications and familiarity with laboratory information and inventory management systems.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screen.

Nice To Haves

Master's degree preferred.
Direct experience in specimen receiving, accessioning, sample processing, or pre-analytical laboratory operations strongly preferred.
Direct people-management experience in a clinical or regulated laboratory environment strongly preferred.
Experience in a clinical laboratory, clinical trials laboratory, diagnostic laboratory or other regulated laboratory environment preferred.
Experience with high-volume or time-sensitive laboratory operations and LIMS/LIS or electronic sample tracking strongly preferred.
Experience with laboratory inventory/materials management, equipment management and temperature-controlled storage operations preferred.
Experience working within a QMS and knowledge of CAP, CLIA, GDP, OSHA and other applicable regulatory requirements preferred.

Responsibilities

Lead daily receiving and accessioning operations, including specimen receipt, inspection, reconciliation, accessioning, data entry, labeling, documentation, sample routing, storage and handoff to downstream laboratory teams.
Ensure specimens are received and processed accurately and in accordance with study requirements, established procedures, quality standards and applicable regulatory requirements.
Maintain sample integrity, chain of custody, traceability and accurate documentation throughout the pre-analytical process.
Monitor workload, turnaround time, productivity, quality metrics and staffing; adjust resources and priorities based on incoming sample volume and business needs.
Troubleshoot specimen discrepancies, missing or conflicting documentation, system issues and other pre-analytical exceptions, ensuring timely escalation and resolution.
Partner with Client Services, Project Management, Quality and laboratory teams to resolve sample-related issues and prevent recurrence.
Drive improvements that reduce accessioning errors, improve turnaround time, standardize workflows and increase operational efficiency.
Oversee laboratory materials management and inventory control to ensure critical supplies and consumables are available to support laboratory operations.
Monitor inventory levels, reorder points, usage trends, expiration dates and material availability to minimize shortages, waste and operational disruptions.
Partner with Supply Chain, laboratory teams and vendors to address material constraints and support changing testing volumes and study requirements.
Ensure materials are received, stored, tracked and maintained according to applicable procedures and quality requirements.
Oversee laboratory equipment and cold storage operations, including refrigerators, freezers and other temperature-controlled units used to store clinical specimens, reagents and laboratory materials.
Ensure equipment and cold storage units are maintained in an appropriate state of readiness, including preventive maintenance, service coordination, utilization monitoring and required documentation.
Respond to escalated cold storage alarms and equipment failures during and outside normal business hours.
Assess operational risk, coordinate troubleshooting and service support, and ensure timely action is taken to protect sample and material integrity.
Support after-hours events through remote assessment and coordination, escalation to appropriate personnel or service providers, and onsite response when necessary.
Ensure alarm response, escalation, backup storage, emergency response and business continuity procedures are established, maintained and followed.
Coordinate sample or material relocation when required and ensure excursions, corrective actions and associated documentation are managed in accordance with the Quality Management System.
Monitor equipment utilization, storage capacity and laboratory demand to identify constraints, operational risks and future capacity needs.
Directly manage and develop employees across Lab Management functions through clear expectations, coaching, feedback, performance management and professional development.
Manage staffing, scheduling, workload allocation, timekeeping, training and competency; participate in recruiting, interviewing, selection and onboarding.
Build a culture of accountability, quality, collaboration, continuous improvement and strong customer service.
Establish and monitor operational metrics and communicate performance, risks, priorities and resource needs to leadership.
Provide hands-on operational leadership when needed to maintain workflow and resolve escalated issues.
Lead or participate in Practical Process Improvement (PPI) initiatives focused on quality, efficiency, capacity, cost and customer experience.
Ensure departmental activities are performed and documented according to approved procedures, the Quality Management System (QMS), Good Documentation Practices (GDP) and applicable regulatory requirements.
Support compliance with applicable clinical laboratory requirements, including CAP, CLIA, OSHA and other relevant quality or regulatory standards.
Participate in internal and external audits, inspections, investigations, corrective and preventive actions and quality management activities.
Develop, review and maintain procedures, work instructions, training materials and other controlled documentation applicable to Lab Management activities.