Senior Staff Scientist, Clinical Assay On Market Support

Illumina seeks an experienced Senior Staff Scientist to lead technical initiatives for on-market clinical assays and library preparation products. The role involves directing complex investigations, troubleshooting, and lifecycle management across oncology, NIPT, and infectious disease portfolios within a regulated product environment.

Responsibilities

• Direct complex technical and cross-functional initiatives supporting on-market assays and troubleshooting projects
• Establish technical direction and guide teams on assay development, product performance, manufacturing issues, and quality events
• Lead risk analyses, FMEAs, design control activities, verification/validation planning, and failure investigations
• Collaborate with scientists, engineers, quality, regulatory, manufacturing, and commercial teams to resolve issues
• Mentor junior scientists and provide technical coaching to project team members

Requirements

• PhD in Genomics, Molecular Biology, Biochemistry, Bioengineering, or related field preferred
• 12+ years related experience with Bachelor's degree; or 8+ years with Master's; or 5+ years with PhD
• Expertise in assay development and on-market product support in regulated environments
• Deep understanding of design controls, risk management, verification/validation, CAPA, and regulatory requirements
• Hands-on experience with next-generation sequencing and Illumina platforms
• Demonstrated ability to lead across multiple disciplines without direct authority
• Strong written and verbal communication skills for technical and leadership audiences

Compensation: $141,600 - $212,400 base salary