Associate Director, Reagent Development

Guardant Health seeks an Associate Director to lead a team developing next-generation sequencing reagents for clinical laboratory products. The role oversees reagent design and optimization from concept through manufacturing scale-up while ensuring compliance with GMP and ISO 13485 standards.

Responsibilities

• Lead and mentor a team of development scientists in NGS reagent design and optimization
• Manage end-to-end development of enzymes, buffers, and chemical reagents for sequencing applications
• Design verification and validation studies and oversee technical design reviews for internal deployment
• Establish quality attributes, stability protocols, and ensure CLIA/CAP and FDA compliance documentation
• Partner with Product Development, Operations, Quality, and Supply Chain on design transfer and scale-up

Requirements

• Ph.D. in Biochemistry, Molecular Biology, Chemistry, or related discipline
• 7-12 years life sciences or clinical diagnostics industry experience with 3+ years in management
• Extensive hands-on reagent or assay development experience for NGS applications
• Direct experience taking NGS reagents from concept through manufacturing implementation
• Proficiency with design control, ISO 13485, cGMP, CLIA/CAP compliance requirements
• Strong expertise in Design of Experiments, statistical analysis, and quality control metrics
• Excellent communication and cross-functional collaboration skills