Staff Scientist
About The Position
Illumina is seeking a Staff Scientist with expertise in IVD assay development and next-generation sequencing to advance molecular diagnostics and precision oncology. This role is part of the Clinical Solutions team supporting pharma-collaborative projects through assay development, formal verification and validation testing, clinical studies, and regulatory submission. The Staff Scientist serves as a Study Lead and technical subject matter expert for assigned studies and technical workstreams, with responsibility for experimental design, data analysis and verification, protocol and report authorship, troubleshooting, and cross-functional decision-making within those areas. The role collaborates closely with internal partners, including Quality, Regulatory, Clinical Affairs, Biostatistics, Software, Bioinformatics, and Operations, as well as external partners, to contribute to project goals and deliverables, present results, identify risks and mitigations, and recommend solutions. At the Staff Scientist level, the position includes expanded technical leadership, mentorship, and business acumen responsibilities.
Requirements
- Expertise in IVD assay development and next-generation sequencing
- Experience with assay development, formal verification and validation testing, clinical studies, and regulatory submission
- Experience as a Study Lead and technical subject matter expert
- Experience with experimental design, data analysis and verification, protocol and report authorship, and troubleshooting
- Experience collaborating with internal partners (Quality, Regulatory, Clinical Affairs, Biostatistics, Software, Bioinformatics, Operations) and external partners
- Technical leadership, mentorship, and business acumen responsibilities
- Knowledge of IVD product requirements, clinical laboratory workflows, and clinical market needs
- Experience with CLSI and other applicable industry standards
- Experience documenting research progress and study outcomes within a Quality Management System consistent with ISO 13485 expectations
- Minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years of experience; or equivalent experience.
Responsibilities
- Provide technical leadership for the initiation, planning, development, troubleshooting, and validation of IVD oncology assays and kits for the clinical market
- Apply knowledge of IVD product requirements, clinical laboratory workflows, and clinical market needs to guide assay and product development decisions
- Drive technical decision-making and continuous improvement across functional and project teams responsible for designing, executing, troubleshooting, analyzing, and presenting experiments
- Lead team execution of formal IVD verification and validation protocols and regulatory reports based on CLSI and other applicable industry standards
- Document research progress and study outcomes within a Quality Management System consistent with ISO 13485 expectations
- Manage and develop scientists through the design, execution, troubleshooting, analysis, and documentation of verification and validation studies
- Author reports and present results, project updates, risks, mitigations, technology assessments, and technical roadmaps to colleagues, senior management, and leadership
Benefits
- Access to genomics sequencing
- Family planning
- Health/dental/vision
- Retirement benefits
- Paid time off
- Variable cash programs (bonus or commission)
- Equity as part of the compensation package
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What This Job Offers
Job Type
Full-time
Career Level
Senior
