Senior Staff Scientist, Clinical Assay On Market Support

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.

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. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

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