Associate Director, Reagent Development

Guardant Health, Inc.; Palo Alto (CA); Hybrid; USD 155,000 - 251,000; Full time

Benefits offered by this job

Hybrid work model

On-site lab facilities

Career development

Job summary

Guardant Health, Inc. seeks an Associate Director Reagent Development to lead a team designing and optimizing NGS reagents for clinical labs, ensuring GMP/ISO 13485 compliance and successful internal implementation.

You will oversee end-to-end reagent development, collaboration across departments, and compliance for CLIA/CAP/FDA environments, with Hybrid work in the Bay Area.

Qualifications

• PhD in Biochemistry, Molecular Biology, Chemistry, or related field with relevant experience.
• 7–12 years in life sciences with 3+ years in leadership or management.
• Deep biochemistry knowledge with experience in enzymology and nucleic acid interactions.

Responsibilities

• Direct a team of development scientists; foster rigor, innovation and teamwork.
• Align project goals with product and clinical lab needs; manage resources and timelines.
• Lead end-to-end development of enzymes and reagents for internal NGS applications.
• Oversee design control, documentation, and regulatory compliance (GMP, ISO 13485).
• Collaborate with Product Development, QA, and Supply Chain for scale-up and transfer.
• Lead design reviews, V&V studies, and phase-gate meetings for internal deployment.

Skills

Biochemistry

Molecular Biology

Leadership

Project management

Design of Experiments

DoE statistics

Education

PhD in Biochemistry or related

Tools

ERP systems

eQMS

Laboratory automation

Job description

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, visitguardanthealth.comand follow the company onLinkedIn,X (Twitter)andFacebook.

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 identifying and providing adequate resources and training to ensure effective work performance which includes meeting regulatory, statutory and customer requirements while also supporting and maintaining the effectiveness of the quality system.
• Perform other duties as assigned.

Qualifications

• Ph.D. in Biochemistry, Molecular Biology, Chemistry, or a closely related discipline; an equivalent combination of education and experience may be considered.
• 7-12 years of industry experience in life sciences, biotechnology, or clinical diagnostics, including 3+ years in a management or leadership role.
• Deep biochemistry knowledge, with a proven track record developing and optimizing complex biochemical systems, enzymology, and nucleic acid interactions.
• Extensive hands‑on experience developing reagents, kits, or assays specifically for next-generation sequencing.
• Demonstrated success in taking at least one NGS reagent or relevant formulation from concept through design transfer and manufacturing implementation.
• Direct experience developing products under strict design control processes within an ISO 13485 and/or cGMP compliant environment.
• Familiarity with CLIA/CAP guidelines and the quality and regulatory requirements for scaling reagents within a high‑throughput clinical laboratory.
• Expertise in Design of Experiments (DoE), statistical analysis, and establishing rigorous QC metrics for reagent formulation.
• Excellent written and oral communication and presentation skills, including the ability to present to cross‑functional partners and senior leadership.
• Strong strategic thinking paired with a willingness to engage hands‑on with the science.
• Excellent attention to detail and documentation rigor.
• Ability to multi‑task, prioritize competing demands, and remain flexible with tasks and schedules.

Preferred

experience managing raw material supply chains and interacting with external vendors for critical reagent components.

AI & Digital Fluency

Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Hybrid Work Model

This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in‑person/onsite collaboration and work‑from‑home days for individual‑focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in‑office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work‑life balance while keeping teams connected to advance our science for our patients.

Compensation

• The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job‑related skills, job duties, and business need.
• Primary Location: Palo Alto, CA
• Primary Location Base Pay Range: $182,200 - $250,500
• Other US Location(s) Base Pay Range: $154,870 - $212,925
• If the role is performed in Colorado, the pay range for this job is: $163,980 - $225,450

Physical Work Requirements

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Accommodations

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [e-mail]

Background Screening

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

Equal Opportunity Employment

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. All your information will be kept confidential according to EEO guidelines. To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

If you like wild growth and working with happy, enthusiastic over‑achievers, you'll enjoy your career with us! Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area.

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