Laboratory Manager

About Wren Laboratories

Wren Laboratories is a growing CLIA-, CAP-, NYSDOH-, and ISO-certified molecular diagnostics laboratory in Branford, Connecticut. Wren develops and performs advanced blood-based molecular diagnostic tests, including innovative oncology assays, and is expanding its testing platforms, clinical programs, and regulatory activities.

We are seeking an experienced, hands-on Laboratory Manager to lead day-to-day clinical laboratory operations and support continued growth.

Position Summary

The Laboratory Manager is responsible for the effective daily operation of the clinical laboratory, including personnel, workflow, specimen processing and testing, turnaround time, quality control, equipment, supplies, training, competency, documentation, and regulatory compliance.

This is an operations-focused leadership position. The successful candidate will take ownership of laboratory performance from specimen receipt through completion of testing and reporting, while working closely with the Laboratory Director, Quality Assurance, scientific staff, and senior management.

Key Responsibilities

· Manage daily laboratory operations to ensure accurate, efficient, and timely testing.

· Coordinate staffing, scheduling, workload distribution, and laboratory coverage.

· Monitor specimen flow, pending work, turnaround time, repeat testing, and operational bottlenecks.

· Troubleshoot workflow, testing, instrument, specimen, and personnel issues and ensure timely resolution.

· Supervise laboratory personnel and support hiring, onboarding, training, competency assessment, cross-training, and performance management.

· Ensure compliance with approved SOPs and applicable CLIA, CAP, NYSDOH-CLEP, ISO 15189, and internal quality-system requirements.

· Maintain continuous inspection and audit readiness and support investigations, root-cause analysis, CAPA, deviations, nonconformances, and QC failures.

· Ensure required laboratory records, logs, QC documentation, equipment records, and training records are complete and current.

· Support assay validation, verification, method transfer, and implementation of new molecular diagnostic tests and technologies with hands on as needed.

· Help transition validated assays into controlled routine laboratory operations.

· Oversee laboratory equipment maintenance, calibration, service coordination, reagent and consumable inventory, and critical supply needs.

· Monitor laboratory capacity, including specimen volume, instrument utilization, staffing needs, turnaround time, repeat rates, equipment downtime, and available space.

· Recommend staffing, workflow, automation, equipment, or shift changes needed to support growth.

· Support laboratory information systems, specimen tracking, testing workflows, and opportunities to reduce manual or transcription errors.

· Participate in internal, regulatory, accreditation, sponsor, and client audits and inspections.

Qualifications Required

· Bachelor’s degree or higher in clinical laboratory science, molecular biology, biochemistry, biological sciences, or a related field.

· Significant experience in a CLIA-regulated clinical laboratory, preferably molecular diagnostics.

· Demonstrated experience supervising laboratory personnel and managing day-to-day laboratory operations.

· Strong knowledge of laboratory quality systems, QC, documentation, training, competency, and regulatory compliance.

· Experience with molecular testing methods such as PCR and/or RT-qPCR.

· Strong organizational, leadership, communication, troubleshooting, and problem-solving skills.

Preferred

· Master’s degree, PhD, or other advanced scientific degree.

· ASCP or other relevant laboratory certification.

· Experience with CAP- and NYSDOH-regulated laboratories.

· Experience with oncology or advanced molecular diagnostics.

· Experience with high-throughput PCR, OpenArray, multiplex testing, automation, or laboratory informatics.

· Experience supporting assay validation, laboratory-developed tests, clinical studies, or FDA-regulated diagnostic development.

Leadership Profile

The ideal candidate is technically strong, highly organized, and hands-on and operations oriented. We are looking for someone who takes ownership of staffing, workflow, quality,

turnaround time, equipment, supplies, and daily laboratory execution, while also helping Wren scale to higher testing volumes and new technologies.

Work Environment

This is a primarily onsite leadership position in Branford, Connecticut. The Laboratory Manager must have sufficient schedule flexibility to support laboratory operations, inspections, training, troubleshooting, staffing needs, and other operational requirements.

Wren Laboratories offers competitive compensation and benefits commensurate with experience and qualifications.