Clinical Laboratory Scientist

*** U.S. Residents Only - No Sponsorship Offered ***Full-Time, OnsiteMon–Fri 8am–5pm, $55/hour6-month contract, potential to move to permanentPosition SummarySeeking a highly motivated Laboratory Research Associate / Clinical Validation Associate to support analytical validation (AV) and clinical validation (CV) activities for OvaPrint™, a cfDNA methylation liquid biopsy assay for ovarian cancer risk assessment. This individual will play a key role in executing wet lab workflows, maintaining high-quality laboratory practices, supporting assay reproducibility studies, and generating data required for CAP/CLIA laboratory validation activities.Required Qualifications• Bachelor’s or Master’s degree in molecular biology, biochemistry, genomics, biotechnology, or related field• Valid California CLS license (Generalist or CGMBS)• 2+ years of hands-on molecular laboratory experience preferred• Experience with NGS workflows, cfDNA, methylation assays, or liquid biopsy technologies strongly preferred• Experience working in a CAP/CLIA, regulated, or quality-focused laboratory environment is a plus• Strong organizational skills and attention to detail• Ability to work independently in a fast-paced startup environment• Excellent documentation and communication skillsKey Responsibilities• Perform molecular biology workflows related to cfDNA extraction, library preparation, methylation-based assays, sequencing preparation, and quality control• Execute analytical validation studies including:• precision/reproducibility• limit of detection• accuracy/concordance• sensitivity/specificity analyses• stability studies• reference interval or cutoff verification as applicable• Support clinical validation activities using prospectively and retrospectively collected plasma specimens• Maintain accurate laboratory records, validation documentation, SOPs, batch records, and QC logs in accordance with CAP/CLIA requirements• Assist with assay troubleshooting, optimization, and process improvement efforts• Coordinate specimen accessioning, sample tracking, and inventory management• Work collaboratively with bioinformatics and data analysis teams to support interpretation of validation results• Assist in preparation of validation summaries, technical reports, and regulatory documentation• Support implementation and maintenance of laboratory quality systems and LIMS workflows• Ensure compliance with laboratory safety procedures and quality standardsPreferred Technical Experience• cfDNA extraction and quantification• NGS library preparation• Illumina sequencing workflows• PCR/qPCR and QC instrumentation• Handling plasma and blood-derived biospecimens• Basic data review and assay QC interpretation