Licensed Clinical Laboratory Scientist II

Position Overview:

The Licensed Clinical Laboratory Scientist (CLS) II or Clinical Genetic Molecular Biologist Scientist (CGMBS) plays a vital role in MyOme's mission to advance precision health through clinical-grade genomic testing. This role is responsible for performing complex molecular and genomic analyses in compliance with CLIA, CAP, and NYS-CLEP standards. The individual will execute validated testing procedures, review and interpret data, ensure quality control and documentation accuracy, and maintain regulatory compliance across all analytical workflows. This position requires exceptional technical precision, strong problem-solving skills, and a collaborative mindset to help deliver high-quality patient results that support MyOme's Integrated Risk Model and Whole Genome Sequencing programs.

What You'll Do:

• Perform and document all phases of molecular and genomic testing (e.g., extraction, library prep, sequencing, data analysis, and reporting) following validated procedures and SOPs.
• Conduct routine and non-routine quality control (QC), proficiency testing (PT), and equipment maintenance in accordance with CAP/CLIA/NYS-CLEP standards.
• Review, interpret, and approve analytical results, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Identify and troubleshoot technical and workflow issues, initiating corrective and preventive actions (CAPA) as necessary.
• Participate in validation, verification, and method comparison studies for new assays and instrumentation.
• Maintain accurate and complete records for all testing activities, reagent logs, and equipment maintenance.
• Support continuous process improvement through Lean/Six Sigma, root cause analysis, and audit readiness initiatives.
• Collaborate with QA, Bioinformatics, and Clinical Affairs teams to ensure seamless data integrity and reporting workflows.
• Participate in ongoing competency assessments, continuing education, and annual training per CLIA and CAP requirements.
• Support inspections (CAP, CLIA, NYS, FDA) and contribute to documentation and evidence preparation as required.

What You'll Need:

• Active California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license (required).
• Bachelor's degree in biological sciences, molecular biology, genetics, or related field (required).
• Minimum of 2+ years of experience in a CLIA-certified high-complexity laboratory (experience with molecular diagnostics or NGS preferred).
• Strong understanding of CAP, CLIA, and NYS-CLEP regulations and quality management principles.
• Experience with genomic testing workflows, including DNA/RNA extraction, PCR/qPCR, NGS library prep, sequencing, and data analysis.
• Familiarity with automation, laboratory information management systems (LIMS) and electronic documentation systems.
• Excellent attention to detail, analytical thinking, and adherence to quality and safety protocols.
• Strong written and verbal communication skills; able to effectively document, communicate, and escalate issues.
• Demonstrated ability to work collaboratively in a multidisciplinary team in a regulated clinical environment.
• Commitment to patient safety, data integrity, and continuous learning in a rapidly evolving genomic testing landscape.

Location, Compensation, and Benefits:

• Location: Onsite full-time at our Menlo Park, CA office.
• Compensation: Annual base salary range is $99,000 - $140,000 depending on experience. In addition, equity will also be provided.