Quality Assurance Specialist – Clinical Genomics

Clinical Laboratory Manager – Molecular Genetics

Location: Austin, TX Work Arrangement: 100% Onsite Employment Type: Full-Time Schedule: Monday–Friday, 1st Shift

About the Opportunity

Lighthouse Lab Services is partnering with an innovative genetic diagnostics organization to identify an experienced Clinical Laboratory Manager for its new clinical laboratory in Austin, Texas.

This organization specializes in advanced genetic testing for patients with rare and complex genetic conditions. Through next-generation sequencing (NGS), whole-exome sequencing (WES), whole-genome sequencing (WGS), and proprietary bioinformatics technology, the company helps physicians identify the genetic causes of rare diseases and provide answers to patients and families who may have spent years searching for a diagnosis.

This is a unique opportunity to join a growing organization during the establishment of its first U.S. clinical laboratory. The selected candidate will play a key role in building laboratory operations, developing workflows, establishing quality systems, and helping shape the culture of the facility from the ground up.

Position Overview

The Clinical Laboratory Manager will serve as the hands-on operational leader for the laboratory, overseeing the establishment and ongoing management of clinical molecular genetics testing operations.

During the initial startup phase, this individual will help develop and validate laboratory workflows, coordinate equipment and operational readiness, and work closely with laboratory leadership and bioinformatics teams. Following the initial build-out, the manager will oversee daily wet-lab operations, including DNA extraction, NGS library preparation, exome and genome sequencing, and Sanger sequencing.

This individual will serve as the CLIA/CAP General Supervisor and work closely with the Laboratory Director to ensure regulatory compliance, testing quality, operational efficiency, and team development.

The ideal candidate will bring extensive hands-on molecular genetics experience, strong knowledge of NGS workflows, and previous laboratory leadership experience. This is a long-term operational leadership position, not a temporary startup or consulting assignment.

Key Responsibilities

Laboratory Establishment & Operations

Help establish and implement laboratory workflows, policies, and procedures for a new clinical molecular genetics laboratory.

Oversee day-to-day laboratory operations, ensuring quality, productivity, and turnaround time targets are consistently met.

Develop operational plans, monitor key performance indicators, and identify opportunities to improve laboratory efficiency.

Coordinate laboratory supply chain needs, inventory planning, and operational readiness.

Support contingency planning and the ongoing development of laboratory infrastructure.

Molecular Genetics & NGS Operations

Oversee end-to-end clinical wet-lab workflows, including DNA extraction, NGS library preparation, whole-exome sequencing, whole-genome sequencing, and Sanger sequencing.

Provide technical leadership and troubleshooting support for complex molecular testing workflows.

Support testing involving low-input and pediatric specimen types, including buccal swabs, saliva, and small-volume blood samples.

Operate, troubleshoot, and optimize automated liquid handling platforms and high-throughput sequencing equipment.

Monitor sequencing quality metrics and ensure testing workflows consistently meet established performance standards.

Assay Validation & Development

Participate in the analytical validation of exome and genome sequencing assays.

Assist with validation protocol development, including sample matrix testing and establishing limits of detection, sensitivity, and specificity.

Collaborate with the Laboratory Director on validation studies and Validation Summary Reports.

Help ensure new testing methods meet applicable regulatory and quality requirements before implementation.

Team Leadership & Development

Serve as the CLIA/CAP General Supervisor for high-complexity testing operations.

Directly supervise, schedule, train, and mentor laboratory technologists.

Develop staffing plans and cross-training initiatives to support laboratory growth and operational needs.

Oversee employee onboarding, training, and competency assessments.

Provide ongoing technical guidance and promote a culture of accountability, quality, and continuous improvement.

Quality Assurance & Regulatory Compliance

Maintain laboratory quality assurance and quality control programs in accordance with applicable regulatory and accreditation requirements.

Support CAP and CLIA compliance, including proficiency testing, quality control review, nonconformance investigations, and inspection readiness.

Develop, review, and maintain laboratory standard operating procedures (SOPs) and other required documentation.

Ensure laboratory records and documentation remain accurate, complete, and audit-ready.

Collaborate with the Laboratory Director on quality management systems and regulatory requirements.

Support inspections and regulatory assessments, including applicable state-specific requirements.

Equipment & Inventory Management

Oversee routine maintenance, calibration, and preventive maintenance schedules for sequencing platforms, automated liquid handlers, and ancillary laboratory equipment.

Manage reagent lot verification, inventory levels, and reorder schedules.

Monitor reagent and equipment quality control to ensure consistent testing performance.

Coordinate with vendors and internal stakeholders to address equipment or supply-related issues.

Continuous Improvement

Identify workflow bottlenecks and implement improvements to increase laboratory efficiency and testing throughput.

Monitor sequencing performance and quality metrics to identify trends and opportunities for optimization.

Develop and implement process improvements that support laboratory growth and long-term operational success.

Required Qualifications

Bachelor's degree or higher from an accredited college or university in Biological Sciences, Clinical Laboratory Science, Medical Technology, Molecular Biology, Genetics, or a related scientific field.

Minimum of 5 years of hands-on experience in a high-complexity clinical molecular genetics or genomic testing laboratory operating under CLIA/CAP standards.

At least 2 years of supervisory or laboratory leadership experience.

Extensive hands-on experience with next-generation sequencing (NGS) workflows, including library preparation for whole-exome and/or whole-genome sequencing.

Experience with high-throughput sequencing platforms, such as Illumina, and Sanger sequencing.

Strong understanding of molecular genetics laboratory operations, instrumentation, and testing workflows.

Working knowledge of CLIA, CAP, and applicable state regulatory requirements.

Experience participating in assay validation activities and developing or reviewing validation protocols.

Ability to collaborate on analytical validation studies and Validation Summary Reports, including limits of detection, sensitivity, and specificity.

Demonstrated ability to lead laboratory personnel, manage daily operations, and maintain quality standards.

Regulatory & Educational Requirements:

This position will serve as the General Supervisor under CLIA regulations (42 CFR § 493.1461). Educational qualifications must also meet applicable California requirements for specimens originating in California, including equivalency to the educational requirements for California Clinical Genetics Molecular Biologist Scientist (CGMBS) licensure. A California license is not required for this position.

Degrees earned outside the United States must be evaluated through a NACES- or AICE-approved organization on a course-by-course basis.

Preferred Qualifications

MB(ASCP) certification.

California CGMBS or Clinical Laboratory Scientist (CLS) license.

Experience with automated liquid handling systems and optimization of NGS workflows.

Previous experience helping establish a new clinical laboratory or supporting a laboratory build-out.

Experience working in a startup, biotech, or rapidly growing molecular diagnostics organization.

Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.

Experience in a children's hospital laboratory or pediatric genetic testing program.

Experience working with international laboratory teams or cross-functional groups involving bioinformatics and clinical leadership.

Compensation & Benefits

The organization offers a competitive compensation package, including:

Medical, dental, and vision insurance for employees and eligible family members.

401(k) retirement plan.

Paid time off.

Paid sick leave.

Company holidays.

Why Consider This Opportunity?

This is a rare opportunity to help build and lead a clinical molecular genetics laboratory from the ground up.

You'll have the ability to influence laboratory operations, establish technical workflows, develop a team, and contribute to the growth of an organization working at the forefront of genetic diagnostics.

For an experienced molecular laboratory professional with NGS expertise and leadership experience, this position offers the opportunity to take ownership of a growing laboratory operation while doing meaningful work that can directly impact patients and families affected by rare genetic diseases.

Interested? Apply today or contact Lighthouse Lab Services to learn more about this opportunity.

About Us

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 22 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual

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