Staff Scientist

Illumina•San Diego, CA

1d•$118,200 - $177,200•Onsite

About The Position

Illumina is seeking an experienced and highly motivated Staff Scientist to help advance molecular diagnostics and precision oncology through the development of next-generation sequencing (NGS) assays. In this role, you will serve as a technical leader within a multidisciplinary product development environment, driving the design, optimization, verification, and validation of innovative oncology assays intended for research and/or clinical applications. The ideal candidate combines deep expertise in molecular biology, assay development, and NGS technologies with a proven track record of leading complex technical initiatives in a fast-paced product development environment. This individual will operate with a high degree of independence, influence cross-functional decision-making, mentor scientists, and contribute to the technical and business strategy of key oncology programs. As a Staff Scientist, you will lead critical technical workstreams, provide subject matter expertise, and partner closely with teams across Quality, Bioinformatics, Biostatistics, Software Development, Operations, Product Marketing, and Commercial organizations to deliver high-impact products that improve patient outcomes.

Requirements

Strong background in molecular biology, genomics, assay development, and next-generation sequencing technologies.
Demonstrated experience leading complex scientific projects and influencing technical decisions across multidisciplinary teams.
Excellent analytical, problem-solving, and troubleshooting skills.
Strong written and verbal communication skills with the ability to effectively communicate complex technical concepts to diverse audiences.
Experience working in a cross-functional product development environment.
Proven ability to independently lead studies from planning through execution, analysis, and final reporting.

Nice To Haves

Experience developing, optimizing, and validating NGS-based oncology assays and workflows.
Expertise in Design of Experiments (DOE) methodologies and data-driven assay optimization approaches.
Experience with regulated product development and quality systems for NGS-based molecular diagnostic IVD products.
Demonstrated success partnering across functions such as Quality, Bioinformatics, Biostatistics, Operations, Software Development, and Commercial organizations.
Prior experience mentoring scientists and providing technical leadership across project teams.

Responsibilities

Lead complex technical workstreams supporting the development of NGS-based oncology assays and products in a fast-paced environment in alignment with industry standards and regulatory expectations.
Serve as the scientific lead for study design, execution, analysis, troubleshooting, and interpretation of experimental results. Analyze large and complex datasets to identify technical risks, develop data-driven recommendations, and communicate tradeoffs and rationale to stakeholders and leadership.
Lead execution of verification and validation activities in accordance with CLSI guidelines and applicable quality system requirements.
Manage and mentor a team of junior scientists through technical coaching, scientific review, and guidance on experimental design, data analysis, and scientific documentation.
Present technical findings, project updates, risk assessments, mitigation plans, technology evaluations, and strategic recommendations to project teams and senior leadership.
Author and review technical documentation, including product development documentation, engineering studies, verification and validation protocols, technical reports, and risk assessments.
Document research activities and study outcomes within a Quality Management System consistent with ISO 13485 principles.
Contribute to technical strategy, roadmap development, and business decisions that influence future product capabilities and portfolio growth.