Lead NGS Assay Validation Director (Remote-Friendly)

Baylor Genetics; Houston (TX); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Baylor Genetics is seeking an experienced professional to lead analytical validation of sequencing-based assays in a highly regulated environment. You will design, execute, and oversee validation studies across germline, somatic, and liquid biopsy applications, ensuring compliance with CLIA, CAP, NYS, and internal standards.

The role requires deep expertise in NGS library preparation, validation parameters, and collaboration with bioinformatics and QA teams to drive product readiness and

Qualifications

• PhD in Molecular Biology, Genetics, Genomics, or related discipline with 6+ years of relevant experience in NGS assay development and validation.
• Demonstrated track record leading validation of clinical NGS assays under CLIA, CAP, NYS, or equivalent regulatory frameworks.
• Strong expertise in NGS library preparation, sequencing platforms, and assay performance characterization.
• Deep understanding of analytical validation parameters, including accuracy, precision, LOD, specificity, reproducibility, and related statistical evaluation.
• Experience collaborating with bioinformatics teams for pipeline verification and integrated assay validation.
• Familiarity with quality management systems, design control, and documentation best practices.
• Excellent problem-solving, communication, and cross-functional collaboration skills.
• Proven ability to lead complex projects and influence without direct authority in a matrixed environment.
• Equivalent combination of education and experience may be considered.

Responsibilities

• Lead validation studies for sequencing-based assays including germline, somatic, and liquid biopsy applications.
• Develop and maintain validation strategies, protocols, and reports that comply with CLIA, CAP, NYS, and internal quality standards.
• Collaborate with Assay Development, Bioinformatics, Quality, and Product teams to align validation strategy with assay design, clinical claims, and product readiness.
• Establish acceptance criteria, reference materials, and performance metrics to support analytical and clinical validation activities.
• Serve as the subject matter expert for NGS validation methods, study design, assay performance characterization, and regulatory expectations.
• Analyze validation data and provide data-driven recommendations for assay optimization, issue resolution, and launch readiness.
• Support regulatory or laboratory inspections and contribute to responses, documentation, or corrective action plans as needed.
• Mentor scientists at different levels and contribute to building a scalable validation function within the R&D organization.
• Maintain up-to-date knowledge of emerging trends, technologies, and regulatory guidance in NGS assay validation and clinical genomics.
• Perform other duties as assigned to support team and organizational objectives.
• Comply with all company policies, procedures, and applicable regulatory requirements.

Education

PhD in Molecular Biology, Genetics, Genomics, or related discipline

MS with 8+ years in NGS assay development and validation

Job description

Baylor Genetics is seeking an experienced professional to lead analytical validation of sequencing-based assays in a highly regulated environment. You will design, execute, and oversee validation studies across germline, somatic, and liquid biopsy applications, ensuring compliance with CLIA, CAP, NYS, and internal standards.

The role requires deep expertise in NGS library preparation, validation parameters, and collaboration with bioinformatics and QA teams to drive product readiness and