Staff Scientist
@ US01 Illumina, Inc.Staff Scientist
About the job
Illumina advances genomic technology to improve health access globally. As a Staff Scientist, you will lead assay development, validation, and research in molecular diagnostics for clinical applications.
Requirements
- 8+ years related experience
- Knowledge of IVD assay development
- Experience in verification and validation
- Strong data analysis skills
- Leadership in scientific projects
Qualifications
- Bachelor's, Master's, or PhD degree
- Experience in molecular diagnostics
- Knowledge of industry standards
- Effective communication skills
Full job description
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.
Key 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
Experience/Education:
Typically requires a 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.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
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