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 visitand follow the company onLinkedInX (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 teams 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.

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 candidates 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: $182200 - $250500 Other US Location(s) Base Pay Range: $154870 - $212925 If the role is performed in Colorado the pay range for this job is: $163980 - $225450