Associate Director, Assay Validation

Baylor Genetics•Houston, TX

2d•Hybrid

About The Position

The Associate Director, Assay Validation will lead the planning, design, and execution of analytical validation studies for sequencing-based assays, including germline, somatic, and liquid biopsy applications. This role involves developing and maintaining validation strategies, protocols, and reports that comply with CLIA, CAP, NYS, and internal quality standards. The position requires collaboration with Assay Development, Bioinformatics, Quality, and Product teams to align validation strategy with assay design, clinical claims, and product readiness. The Associate Director will establish acceptance criteria, reference materials, and performance metrics, and serve as a subject matter expert for NGS validation methods, study design, assay performance characterization, and regulatory expectations. Responsibilities also include analyzing validation data, providing data-driven recommendations, supporting regulatory inspections, mentoring scientists, and staying current with trends in NGS assay validation and clinical genomics.

Requirements

PhD. in Molecular Biology, Genetics, Genomics, or a related discipline with 6+ years of relevant experience; or M.S. with 8+ years of 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, limit of detection, 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.

Nice To Haves

Prior experience with germline clinical genetic testing or prenatal liquid biopsy testing.
Knowledge of NYS clinical test submission requirements or FDA IVD development processes.
Experience managing a small team.
Familiarity with automation or process scaling for NGS workflows.

Responsibilities

Lead the planning, design, and execution of analytical 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.