Associate Director, Reagent Development

Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Position Summary: The Associate Director Reagent Development leads a team of development scientists in the design, development, and optimization of next-generation sequencing (NGS) reagents for use within Guardant Health clinical laboratory products. The role guides reagent programs from early-stage proof of concept through successful internal implementation, and is accountable for ensuring that all development, formulation, and internal scale-up activities adhere to GMP and ISO 13485 quality standards in support of clinical testing operations. This position is a replacement requisition for an existing role. Essential Duties and Responsibilities: Direct a team of development scientists, fostering a culture of flexibility, adaptability, scientific rigor, innovation, and teamwork. Gain strategic alignment with leaders and deliver on project goals, allocate resources, and manage timelines in collaboration with clinical project management to ensure assay and reagent development milestones align with product and clinical laboratory needs. Capability and desire to complement their team’s work product with individual contributions in the lab and with drafting program and protocol documentation and interest to provide mentorship outside of their direct line of reporting. Demonstrated capabilities to successfully manage development activities under design control and change management processes. Leverages deep technical expertise and executive-level influence to guide resolution of complex biochemical and molecular challenges, provide strategic direction on reagent optimization, and effectively persuade stakeholders to successful resolution of critical issues in clinical testing. Lead the end-to-end development, formulation, and optimization of enzymes, buffers, and chemical reagents for internal NGS applications, including library preparation, target enrichment, and sequencing chemistries. Versant in automated liquid handling systems, including method development criteria and limitations Design and execute robust verification and validation (V&V) studies tailored to internal manufacturing workflows. Lead technical design reviews and phase-gate meetings for internal deployment. Partner closely with Product Development, Operations, Quality Assurance, and Supply Chain to ensure seamless design transfer, scale-up, and internal production of NGS reagents. Comfortable with ERP and eQMS systems Establish critical quality attributes (CQAs) and stability testing protocols for raw materials and finished reagents. Oversee and contribute to the generation of design control and validation documentation, including standard operating procedures (SOPs), batch records, and quality control specifications required for CLIA/CAP and FDA compliance. Collaborate with the Bioinformatics team to ensure reagent specifications meet required assay performance metrics and turnaround times. Participate in audits with external vendors supplying critical reagent components. Ensure all reagent development and internal manufacturing activities comply with ISO 13485 standards, Good Manufacturing Practices (GMP), and the internal Quality Management System (QMS). Responsible for ensuring customer requirements are determined, documented and met. Responsible for ide…

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