Reporting Clinical Laboratory Scientist

The Prenatal Reporting Clinical Laboratory Scientist (RCLS) contractor is responsible for performing high-complexity clinical laboratory data analysis, reviewing and interpreting molecular diagnostic and sequencing results, and ensuring the accuracy, reliability, and timely reporting of patient results in accordance with established laboratory procedures and applicable regulatory requirements.

The RCLS independently executes validated bioinformatics pipelines, evaluates analytical results and quality control metrics, troubleshoots, and reviews and releases clinical laboratory reports within established authorization and reporting procedures. For complex or unusual results requiring additional evaluation, the RCLS collaborates with Bioinformatics, the Laboratory Directors, and other appropriate clinical personnel to ensure accurate interpretation and reporting.

In addition to routine clinical reporting responsibilities, the RCLS is expected to demonstrate technical leadership by exercising sound scientific judgment, independently investigating complex analytical issues, providing technical guidance to colleagues, supporting personnel training, and identifying opportunities for continuous process improvement. The RCLS may also participate in additional technical leadership activities and cross-functional initiatives as assigned by laboratory leadership.

The RCLS collaborates closely with Laboratory Operations, Bioinformatics, Quality Assurance Management, Genetic Counselors, the Laboratory Directors and other cross-functional teams to support accurate clinical reporting, resolve technical challenges, and maintain efficient laboratory workflows.

The nature of this position requires exceptional attention to detail, strong analytical and problem-solving skills, excellent written and verbal communication, and the ability to manage multiple priorities in a fast-paced clinical laboratory environment. The successful candidate must demonstrate initiative, accountability, adaptability, and the ability to work both independently and collaboratively. This role is a hybrid work arrangement requiring approximately 60% on-site presence at the Union City and/or Menlo Park offices (three days per week on-site and two days per week remote).

Responsibilities:

Analysis and Reporting (70%)
Clinical Genomic Data Analysis and Interpretation

• Execute established and validated bioinformatics pipelines to process and analyze molecular diagnostic data from patient samples.
• Independently review and interpret clinical genomic data, including sequencing results, bioinformatics outputs, and associated quality control metrics, to ensure results meet established quality standards and reporting criteria.
• Identify, investigate, and troubleshoot analytical discrepancies, unusual findings, and potential data quality issues, collaborating with Bioinformatics and other appropriate technical teams to resolve complex issues as needed.
• Independently manage daily sample analysis priorities, monitor analytical workflows, and proactively communicate technical issues or concerns that may impact reporting accuracy or turnaround times.

Clinical Reporting and Quality Review

• Independently review, verify, and release clinical laboratory reports in accordance with established procedures, documented personnel authorization, and applicable regulatory requirements.
• Collaborate with other RCLSs, Bioinformatics, Genetic Counselors, Laboratory Directors, and other appropriate clinical personnel to evaluate complex findings, resolve reporting discrepancies, and obtain additional review or approval when necessary.
• Ensure the accuracy, completeness, and consistency of clinical reports while managing daily reporting priorities and maintaining established quality standards and turnaround time expectations.
• Maintain accurate documentation of analytical reviews, quality assessments, investigations, and reporting decisions in accordance with established laboratory procedures.
• Communicate reporting concerns and unresolved issues promptly to appropriate personnel, supporting continuity of reporting operations and timely resolution of sample-specific issues.

Technical Leadership, Quality Assurance, and Operational Support (30%)
Technical Leadership and Training

• Demonstrate initiative, accountability, and sound scientific judgment when performing clinical data analysis and reporting responsibilities.
• Independently investigate complex analytical discrepancies, troubleshoot technical issues, and identify appropriate solutions or escalation pathways.
• Serve as a technical resource for other Reporting CLS personnel by sharing knowledge, providing guidance, and supporting consistent application of established analytical and reporting procedures.
• Assist with training, onboarding, and mentoring Reporting CLS personnel and other clinical laboratory staff as appropriate.
• Promote technical competency, reporting consistency, and adherence to established laboratory procedures and quality standards.
• Proactively identify opportunities to improve reporting accuracy, workflow efficiency, and overall laboratory performance.
• Participate in additional technical leadership activities, such as coordinating technical investigations, supporting validation projects, or contributing to workflow improvements, as assigned by laboratory leadership.

Quality Assurance and Regulatory Compliance

• Perform and support quality control and quality assurance activities to maintain the accuracy, reliability, and integrity of clinical laboratory testing and reporting.
• Ensure compliance with applicable Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), California state regulations, and established laboratory policies and procedures.
• Identify, document, and investigate quality-related issues, including analytical discrepancies, nonconforming results, and deviations from established procedures.
• Collaborate with Quality Management and laboratory leadership to support root cause investigations, corrective and preventive actions, and continuous quality improvement initiatives.
• Maintain accurate documentation and records in accordance with established quality management and regulatory requirements.

Process Improvement and Workflow Optimization

• Identify and recommend opportunities to optimize analytical workflows, improve reporting accuracy, enhance operational efficiency, and promote cost-effective laboratory practices.
• Collaborate with Laboratory Operations, Bioinformatics, Genetic Counselors, and Process Engineering teams to support the development, validation, implementation, and optimization of new or updated laboratory tests, analytical methodologies, and reporting workflows.
• Assist with technology transfer and implementation of validated methodologies from Process Engineering into the clinical laboratory.
• Support the evaluation and implementation of improvements to laboratory data management and reporting systems.
• Maintain and update reporting procedures, technical documentation, and workflow resources to ensure accuracy, consistency, and compatibility with established laboratory processes.
• Participate in investigations of recurring analytical or workflow issues and contribute to the development and implementation of appropriate solutions.

Cross-Functional Collaboration and Operational Support

• Collaborate with Laboratory Operations, Bioinformatics, Genetic Counseling, Client Services, Quality Assurance Management, and Process Engineering to investigate and resolve sample-specific and workflow-related issues.
• Communicate analytical findings, technical concerns, and recommended solutions clearly and effectively to relevant stakeholders.
• Serve as a technical point of contact for cross-functional teams when addressing clinical reporting questions or troubleshooting analytical issues, as appropriate.
• Support laboratory leadership with reporting priorities, operational coordination, and project deliverables as needed.
• Contribute to cross-functional initiatives that improve laboratory efficiency, reporting reliability, and overall operational performance.

Qualifications:

• Must possess an active and valid CLS or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the state of California pursuant to Division 2, Chapter 3 of the California Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to Division 2, Chapter 5 of the California Business and Professions Code appropriate to the specialty they are performing
• Bachelor's degree or higher in Biomedical Laboratory Sciences, Clinical Laboratory Science, Molecular Biology, Genetics, or a related scientific discipline, consistent with applicable licensure requirements.
• At least one year of clinical laboratory experience or equivalent experience in a high-complexity, high-volume molecular diagnostic clinical laboratory environment.
• Working knowledge of molecular biology principles, clinical laboratory testing methodologies, and applicable local, state, and federal laboratory regulations.
• Demonstrated experience with sequencing data analysis, including evaluation and interpretation of next-generation sequencing (NGS) results and associated analytical quality control metrics in accordance with validated laboratory procedures.
• Demonstrated ability to independently analyze complex laboratory data, investigate discrepancies, and troubleshoot issues affecting test performance or reporting accuracy.
• Familiarity with bioinformatics analysis outputs and their application to clinical molecular diagnostic reporting.
• Strong computer skills and the ability to effectively use laboratory data management systems and analytical software. Proficiency with commonly used workplace and collaboration tools, including Atlassian Suite, Google Workspace, and Microsoft Office Suite.
• Strong analytical judgment, attention to detail, and organizational and problem-solving skills, with a commitment to accurate and reliable clinical reporting.
• Ability to independently manage reporting responsibilities, prioritize competing demands, and adapt to changing operational needs while maintaining quality and turnaround time expectations.
• Demonstrated initiative and accountability in investigating technical issues, identifying solutions, and exercising appropriate judgment regarding consultation and escalation.
• Excellent written and verbal communication skills, with the ability to provide technical guidance and collaborate effectively across multidisciplinary teams.
• Receptiveness to feedback and commitment to continuous learning, professional development, and process improvement.

Benefits And Perks:

• Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
• The ability to indirectly or directly change the lives of hundreds of thousands patients
• Daily on-site lunches provided from top eateries
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)

For this position, the target hourly rate is: $65 per hour.

BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.