NGS Assay Validation Director (Remote)

Baylor Genetics; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

Baylor Genetics seeks a senior scientist to lead analytical validation studies for sequencing-based assays, including germline, somatic, and liquid biopsy projects. You will design validation strategies, develop protocols, and ensure compliance with CLIA, CAP, NYS, and internal standards.

You will collaborate with Assay Development, Bioinformatics, Quality, and Product teams, mentor junior staff, and help scale the validation function within R&D while staying current with regulatory guidance in

Qualifications

• PhD in Molecular Biology, Genetics, Genomics, or related with 6+ years in NGS assay development/validation.
• Track record leading validation of clinical NGS assays under CLIA, CAP, NYS, or equivalent.
• Strong expertise in NGS library preparation, sequencing platforms, and assay performance.
• Deep understanding of analytical validation parameters and related statistics.
• Experience collaborating with bioinformatics teams for pipeline verification.
• Familiarity with quality management systems and design control.
• Excellent problem-solving, communication, and cross-functional collaboration skills.
• Equivalent combination of education and experience may be considered.

Responsibilities

• Lead planning, design, and execution of analytical validation studies for sequencing-based assays (germline, somatic, liquid biopsy).
• Develop and maintain validation strategies, protocols, and reports compliant with CLIA, CAP, NYS, and internal standards.
• Collaborate with Assay Development, Bioinformatics, Quality, and Product teams to align validation strategy with assay design.
• Establish acceptance criteria, reference materials, and performance metrics for validation activities.
• Serve as SME for NGS validation methods, study design, and regulatory expectations.
• Analyze validation data and provide data-driven recommendations for assay optimization and launch readiness.
• Support regulatory or laboratory inspections and contribute to responses and corrective actions.
• Mentor scientists and contribute to building a scalable validation function within R&D.
• Maintain up-to-date knowledge of emerging trends, technologies, and regulatory guidance in NGS validation and clinical genomics.
• Perform other duties as assigned and comply with company policies.

Skills

Problem solving

Communication

Cross-functional collaboration

Leadership

NGS library preparation

Analytical validation parameters

Statistics

Bioinformatics collaboration

Quality management

Education

PhD in Molecular Biology/Genetics/Genomics

MS in related field

Tools

Sequencing platforms

Job description

Baylor Genetics seeks a senior scientist to lead analytical validation studies for sequencing-based assays, including germline, somatic, and liquid biopsy projects. You will design validation strategies, develop protocols, and ensure compliance with CLIA, CAP, NYS, and internal standards.

You will collaborate with Assay Development, Bioinformatics, Quality, and Product teams, mentor junior staff, and help scale the validation function within R&D while staying current with regulatory guidance in