Clinical Laboratory Manager (Molecular Genetics)

About 3billion

3billion is a leading genetic diagnostic company dedicated to ending the diagnostic odyssey for children and other patients with rare genetic diseases. We are a global pioneer in AI-driven genetic diagnostics, leveraging our proprietary bioinformatics pipeline to deliver rapid, accurate Exome (ES) and Genome Sequencing (GS) tests. Having successfully served patients and physicians in over 75 countries, we are now entering a new chapter: launching our first US clinical laboratory in Austin, Texas. Joining now means founding-team ownership: you will help build our US lab's people, processes, and culture from day one, backed by a platform already delivering results worldwide. We are looking for a dedicated and meticulous Clinical Laboratory Manager to be the hands-on leader driving our diagnostic engine. If you are passionate about molecular biology and want your daily work to directly impact the lives of children and families waiting for answers, join us. Discover more about our global impact at https://3billion.io/ (opens in a new tab)

Role Overview

As the Clinical Laboratory Manager, you will serve as the vital bridge between wet-bench laboratory staff, bioinformatics specialists, and clinical directors during our startup phase, before transitioning to run the day-to-day operations of our Austin wet lab. After an initial build-out and validation phase, you will oversee the daily NGS workflow, manage and mentor laboratory technologists, maintain quality and compliance, and keep the lab running reliably day in and day out. You will serve as the CLIA/CAP General Supervisor for the laboratory, working closely with our Laboratory Director and coordinating with our Korea headquarters as needed (which may include occasional early-morning or evening meetings across time zones). This is a hands-on operational leadership role, not a launch-only or consulting position. As part of our founding lab team, you will help shape how the lab works day to day, and your responsibilities will grow with the lab.

Core Responsibilities

• • Lab Establishment & Operations: Help establish and oversee initial laboratory workflows to support quality and productivity targets. Support contingency planning, monitor operational KPIs, and coordinate supply chain needs for ongoing operations.
• • Assay Validation & Execution: Contribute to the analytical validation of ES/GS assays, including designing protocols, sample matrix testing, and defining limits of detection (LoD), sensitivity, and specificity. Support the creation and review of Validation Summary Reports in conjunction with the Laboratory Director.
• • Daily Bench Operations & NGS Workflow: Own the end-to-end clinical wet-lab workflow, with daily oversight of DNA extraction, NGS library prep, ES/GS sequencing, and Sanger sequencing, including workflows for low-input pediatric sample types (e.g., buccal swabs, saliva, and small-volume blood). Serve as the primary technical expert for troubleshooting bench issues, and operate and optimize automated liquid handling platforms to sustain throughput and turnaround time (TAT).
• • General Supervision & Team Development: Serve as the CLIA/CAP General Supervisor. Directly supervise, schedule, train, and mentor laboratory technologists. Drive workforce planning and cross-training, and provide on-site oversight of high-complexity testing. Perform and document competency assessments and onboarding.
• • Reagent, Lot & Inventory Management: Manage reagent lot verification, inventory, and reorder cycles; oversee QC monitoring so the lab never runs short or drifts out of specification.
• • SOPs & Documentation: Author, revise, and maintain SOPs and laboratory records; keep documentation audit-ready.
• • Instrument Maintenance & QC: Oversee routine instrument maintenance, calibration, and preventive-maintenance scheduling for sequencers, liquid handlers, and ancillary equipment.
• • Quality & Compliance: Execute and maintain the lab's QA/QC program and support CAP/CLIA compliance under the direction of the Laboratory Director, including proficiency testing, QC review, nonconformance investigations, and continuous inspection readiness.
• • Continuous Quality Improvement: Proactively identify workflow bottlenecks, trend sequencing quality metrics, and implement optimization protocols to maximize laboratory efficiency.

Required Qualifications

• • Education: Bachelor's degree or higher from an accredited college or university in a biological science, clinical/medical laboratory science, medical technology, or a field related to genetics (e.g., Molecular Biology, Genetics, Biology, Medical Laboratory Science). Degrees earned outside the U.S. require a NACES or AICE course-by-course evaluation.
  • • Regulatory role: This position serves as General Supervisor under CLIA (42 CFR § 493.1461) and, for specimens originating in California, under California regulations (17 CCR § 1036.1). The candidate's educational qualifications must be equivalent to those required for California CGMBS licensure. California license not required.
• • Experience: 5+ years of hands-on experience in a high-complexity clinical molecular genetic/genomic testing lab (CLIA/CAP), including at least 2 years in a supervisory or lead role.
• • Deep Genomic Knowledge: Extensive, hands-on experience with NGS library prep (ES/GS), high-throughput sequencing platforms (Illumina, etc.), and Sanger sequencing.
• • Regulatory Fluency: Advanced working knowledge of CAP, CLIA, CDPH LFS, and NYSDOH standards, with a proven track record of navigating regulatory inspections and supporting Quality Management Systems.
• • Analytical Skills: Demonstrated ability to collaborate on Validation Summary Reports and design validation protocols (LoD, sensitivity, specificity).

Preferred Qualifications

• • Certification: MB(ASCP) certification or a California CGMBS/CLS license is highly preferred and strongly valued.
• • Automation: Proven track record of operating and optimizing automated lab equipment for NGS workflows.
• • Startup Mindset: Experience in a de novo lab build-out or a fast-growing biotech environment.
• • Process Improvement: Familiarity with Lean or Six Sigma methodologies in a laboratory setting.
• • Pediatric Experience: Experience in a children's hospital laboratory or pediatric genetic testing program.

Why Join Us? (Compensation & Benefits)

We offer a competitive compensation package and, through a US Professional Employer Organization (PEO), comprehensive benefits:

• • Medical, Dental, and Vision coverage for you and your family
• • 401(k) retirement plan
• • PTO, paid sick leave, and company holidays

3billion US, Inc. is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by law.

If you need a reasonable accommodation to apply or interview, contact jobs@3billion.io.

Employment offers are contingent on a background check, conducted after a conditional offer and in accordance with applicable law, including the Fair Credit Reporting Act. The check includes verification of education, licensure, and certifications.