Associate Director, Assay Validation

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

KEY 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.

QUALIFICATIONS

Required

• 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.

Preferred:

• 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.

COMPETENCIES

• Scientific rigor and strong attention to detail.
• Strategic thinking with hands-on execution capability.
• Collaborative mindset with strong communication across scientific and business functions.
• Commitment to quality, compliance, and continuous improvement.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Location: Houston, TX / Remote.
• Work may be performed in an office, remote, and/or laboratory environment depending on business needs and assigned responsibilities.
• May require exposure to standard laboratory conditions and adherence to applicable safety, quality, and regulatory requirements.
• Must be able to use standard office equipment and computer systems for extended periods.
• Travel requirements may vary based on business needs.

EEO STATEMENT

Baylor Genetics is proud to be an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome and encourage applicants from all backgrounds to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, pregnancy, childbirth, or any other status protected by applicable federal, state, or local law.

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.