Staff Scientist

Illumina; San Diego (CA); On-site; USD 118,000 - 177,000; Full time

Benefits offered by this job

Genomics sequencing access

Family planning benefits

Health/dental/vision insurance

Retirement benefits

Paid time off

Job summary

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 leads studies, designs experiments, analyzes data, and authors reports while coordinating with Quality, Regulatory, and Clinical Affairs teams.

The position includes expanded technical leadership, mentorship, and business acumen responsibilities within the Clinical Solutions group.

Qualifications

• Minimum 8 years of related experience with a Bachelor’s degree; or 6 years with a Master’s; or a PhD with 3 years of experience.
• Experience leading IVD assay development and verification/validation under CLSI/ISO standards.
• Strong data analysis, protocol and report writing, and cross-functional collaboration.

Responsibilities

• Provide technical leadership for initiation, planning, development, troubleshooting, and validation of IVD oncology assays and kits for the clinical market.
• Guide assay and product development decisions considering clinical lab workflows and market needs.
• Lead formal verification/validation protocols and regulatory reports per CLSI and applicable standards.
• Document research progress and study outcomes within a Quality Management System aligned with ISO 13485.
• Mentor scientists through verification/validation study design and execution.
• Author reports and present results, updates, risks, mitigations, and technology roadmaps to management.

Skills

IVD assay development

Next-generation sequencing

Technical leadership

Mentorship

Education

Bachelor’s degree

Master’s degree

PhD

Job description

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life‑changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

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.

The estimated base salary range for the Staff Scientist role based in the United States of America is: $118,200 - $177,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity.

Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package.

We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

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 [e-mail].

To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

This role is not eligible for visa sponsorship.

The potential of genomics to change the world is unparalleled. At Illumina, we are leading the way. Our technology empowers researchers and clinicians globally to improve cancer treatments, change the course of diseases, protect the environment, and fight food insecurity. We are made up of dedicated professionals, all‑in on creating a better world – and we need every skill set on our path to making genomics useful for all. Learn more about life at Illumina.