Senior Staff Scientist, Clinical Assay On Market Support
About The Position
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.
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.
Nice To Haves
- People leadership or functional management experience is desirable but not required.
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.
Benefits
- access to genomics sequencing
- family planning
- health/dental/vision
- retirement benefits
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
