Director Assay Product Development

Baylor Genetics • Houston, TX

2d

About The Position

We are seeking an experienced Director of Assay Product Development to lead our next-generation sequencing (NGS) assay development initiatives. This leader will drive the design, optimization, and launch of innovative NGS-based assays, ensuring clinical accuracy and usability that meet the needs of patients and healthcare providers. The Director will have direct management responsibility for an assay development team, providing mentorship, technical guidance, and performance management. This role will collaborate closely with validation, laboratory operations, and product management teams to ensure seamless integration of assay development with product requirements and operational workflows.

Requirements

• PhD or equivalent experience in molecular biology, genetics, or a related field.
• A minimum of 7 years of experience in assay development, including at least 3 years focused on NGS technologies, with 3 or more years in a leadership or management capacity.
• Deep expertise in NGS wet ‑ lab workflows (e.g., library prep, target enrichment, cfDNA workflows, QC metrics).
• Proven track record in NGS assay development.
• Strong people management skills with experience leading teams in a product development environment.
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Excellent organizational, communication, and leadership skills.
• Strong understanding of clinical laboratory environments and regulatory expectations (CLIA/CAP; NYS preferred).

Responsibilities

• Lead and manage a team of assay scientists in the development of NGS-based assays.
• Oversee project planning, resource allocation, and timeline management to ensure on-time completion of key milestones.
• Define assay design strategies (e.g., panel content, chemistry, workflow, performance targets) aligned with intended clinical use, regulatory expectations, and product requirements.
• Translate product requirements and clinical claims into executable technical development plans in partnership with Product Management.
• Collaborate with Bioinformatics and Automation teams to ensure seamless integration of wet ‑ lab workflows with analysis pipelines and LIMS.
• Collaborate with validation, lab operations, and product teams to ensure robust assay design, validation, and transfer to manufacturing.
• Drive innovation in assay design, keeping abreast of emerging technologies and regulatory requirements.
• Establish and maintain best ‑ in ‑ class assay development processes, documentation standards, and design controls appropriate for clinical diagnostics.
• Identify technical risks early and proactively drive mitigation strategies across functions.
• Provide technical leadership and strategic direction for product development initiatives.
• Communicate progress, challenges, and achievements to executive leadership and cross-functional stakeholders.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree