Senior Staff Scientist, Clinical Assay On Market Support

Illumina; San Diego (CA); On-site; USD 142,000 - 212,000; Full time

Benefits offered by this job

Bonus program

Equity

Comprehensive benefits

Job summary

Illumina in San Diego is seeking a Senior Staff Scientist for On-Market Support. You will lead cross-functional teams to drive design changes, investigations, and lifecycle management for clinical assays including Oncology and NIPT.

The role requires a strong background in genomics, molecular biology, and next-generation sequencing, with hands-on leadership in a regulated product environment. Excellent communication and mentoring are essential as you partner with Regulatory, Quality, and

Qualifications

• PhD in Genomics or related field preferred.
• 12+ years in genomics or assay development.
• Experience leading cross-functional, regulated product teams.
• Strong knowledge of design controls and risk management.
• Excellent communication and mentoring skills.

Responsibilities

• Lead cross-functional activities for on-market assays.
• Set technical direction for assay development and lifecycle management.
• Evaluate risks and communicate tradeoffs to teams and leadership.
• Collaborate with Scientists, Engineers, Bioinformaticians, Software, Quality, Regulatory, Manufacturing, Marketing.
• Lead or guide risk analyses, FMEAs, design control activities, CAPAs.
• Support communications to the field and customers with Marketing, Regulatory, Quality, and Commercial teams.
• Mentor junior scientists and provide technical coaching.

Skills

Genomics

Molecular biology

Assay development

NGS experience

Leadership

Cross-functional collaboration

Regulatory understanding

Data analysis

Education

PhD in Genomics

Related field

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 an experienced Senior Staff Scientist to join the Assay On-Market Support and Development team. This team supports investigations, improvements, and lifecycle management for a broad portfolio of on-market library prep and clinical assay products, including Oncology, NIPT, whole genome sequencing, and infectious disease products. In this role, you will serve as a senior technical leader within a multidisciplinary team working to ensure Illumina products meet performance, quality, regulatory, and customer expectations. The foundation for this role is a strong background in molecular biology, assay development, and next-generation sequencing, with demonstrated experience leading complex technical work in a regulated product environment.

Responsibilities

• Lead complex technical and cross-functional activities supporting on-market assays to drive design changes, troubleshooting projects, and investigations.
• Set technical direction and guide project teams in areas of assay development, product performance, manufacturing issues, quality events, and lifecycle management.
• Independently evaluate technical risks, develop data-driven recommendations, and communicate rationale and tradeoffs to cross-functional teams and leadership.
• Work effectively with Scientists, Engineers, Bioinformaticians, Software, Quality, Regulatory, Manufacturing, Commercial, and Marketing partners to resolve product and customer-impacting issues.
• Lead or guide risk analyses, FMEAs, design control activities, verification and validation planning, CAPAs, and failure investigations.
• Support communications to the field and customers in partnership with Marketing, Regulatory, Quality, and Commercial teams.
• Mentor junior scientists and provide technical coaching to project team members.

Requirements

• Typically requires a minimum of 12 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years of experience; or equivalent experience.
• Ph.D. in Genomics, Genetics, Molecular Biology, Biochemistry, Bioengineering, or related field is preferred.
• Experience in assay development, product development, or on-market product support; or equivalent education and experience.
• Experience leading complex technical work in a product development, regulated product, or lifecycle management environment.
• Strong understanding of design controls, risk management, verification and validation, change management, CAPA, failure investigation, and regulatory expectations for clinical or regulated products.
• Demonstrated ability to work across multiple disciplines, including R&D, Quality, Regulatory, Manufacturing, Bioinformatics, Software, Commercial, and Marketing.
• Excellent verbal and written communication skills, including the ability to summarize complex technical information for cross-functional and leadership audiences.
• Strong organizational and time-management skills, including the ability to manage multiple projects simultaneously in a fast-paced environment.
• Demonstrated ability to mentor technical contributors and influence project direction without direct authority.
• Hands-on experience with next-generation sequencing technologies and Illumina sequencing platforms.
• Experience with Illumina sample preparation methods, library preparation assays, enrichment workflows, or clinical assay portfolios such as NIPT or Oncology.
• Experience supporting on-market IVD, RUO, or clinical products, including investigations, field issues, design changes, quality events, and regulatory-impact assessments.
• People leadership or functional management experience is desirable but not required.
• All listed requirements are deemed essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

The estimated base salary range for the Senior Staff Scientist, Clinical Assay On Market Support role based in the United States of America is: $141,600 - $212,400. 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].

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.

This role is not eligible for visa sponsorship.