Senior Staff Scientist, Clinical Assay On Market Support
Illumina
Summary
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.
Job description
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.
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.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- Paid time off
- Genomics sequencing access
- Family planning
- Bonus program
- Equity
Company overview
Illumina is a global leader in genomics technology, founded in 1998 and headquartered in San Diego, California. As a pioneering biotechnology company, Illumina specializes in developing, manufacturing, and marketing integrated systems for genetic analysis, with a primary focus on DNA sequencing and array-based technologies. The company's mission is to improve human health by unlocking the power of the genome, serving customers across research, clinical, and applied markets worldwide. Illumina's innovative platforms, including the NovaSeq, HiSeq, MiSeq, and NextSeq series, have revolutionized genomic research and clinical applications, enabling breakthroughs in personalized medicine, disease research, and drug development. With over 9,000 employees across 27 countries, Illumina has established itself as the dominant force in next-generation sequencing, processing more than 90% of all DNA sequencing data globally. The company's technologies support diverse applications from cancer research and rare disease diagnosis to agricultural genomics and infectious disease surveillance, making genomic insights accessible to researchers and clinicians worldwide.