Staff Scientist - Oncology On Market Support and Development

Responsibilities

• Lead and execute large-scale technical development or product development projects, including activity planning, requirement definition, risk management, and ownership of deliverables.
• Operate independently, managing individual project workstreams and delivering results with minimal oversight.
• Successfully work cross functionally with and / or lead Scientists, RA's, Engineers, Bioinformaticians, SW, quality, manufacturing and commercial personnel to optimize assay conditions and manufacturing / QC processes to achieve commercial levels of stability, robustness, and performance.
• Apply knowledge of Product Development Processes (PDP) at a cross-functional level.
• Represent the function in a core and project core team; influence cross-functional decisions impacting technology and product development.
• Understand and apply principles of Quality Management Systems (QMS) to maintain compliance and support product excellence.
• Lead risk analysis and FMEA activities for project team.
• Partner with Marketing, Regulatory, and other stakeholders to support communications to the field and to our customers.
• Mentor and guide junior scientists, engineers, and peers in both technical skills and able to delegate sub-tasks and troubleshooting to enable an efficient use of resources and team growth.
• Build and maintain strong collaborative relationships across functions, fostering a culture of learning, innovation, and inclusion.
• Communicate effectively with multidisciplinary teams and senior leadership regarding project status, risks, and recommendations.
• Resolve technical challenges to keep teams accountable on projects tasks and projects on track.

Requirements

• Typically requires a PhD in biochemistry, molecular biology, genetics, genomics, bioengineering or related field with 3+ years relevant experience, MS with 6+ years, BS with 8+ years.
• Participation in the product development, verification and validation, regulatory submission, and successful launch of a clinical diagnostic device for regulated markets; demonstrated knowledge of design controls and risk management
• Experience with transfer of new products to manufacturing and/or QC preferred
• Demonstrated understanding of project management or able to collaborate effectively with project/program managers and able to drive both new product development and improvement initiatives for on-market products while maintaining intact the product intended for use by clinical customers.
• Proven ability to lead project subfunctions and core teams, including technical planning, resource delegation, and milestone tracking.
• Strong collaboration and communication skills, with the ability to independently work in fast-paced, cross-functional environments.
• Comfortable reprioritizing project work in response to changing needs of on-market products.
• Hands-on, proactive approach to problem-solving and continuous improvement.
• Why Join Us?
• In this role, you will have the opportunity to work on impactful products that directly impro

Benefits

Additional Information

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. We are seeking an accomplished and motivated Staff Scientist to join Illumina's On-Market Support and Development (OMSD) team within the Assay Development organization. Based in San Diego, this role supports the continued success and evolution of our TruSight Oncology assays. As part of this team, you will have the opportunity to work with a wide range of Illumina library prep products, as well as sequencing and analysis platforms. You will be a technical expert within a multi-disciplinary team working to ensure Illumina products meet their stated claims, customer expectations, and remain competitive in the markets they serve. The foundation for this role is a solid grasp of molecular biology. If you're looking for a role where you'll make a direct impact with on-market assays and patient outcomes this could be a great fit! This role is ideal for a strategic, hands-on scientific leader with deep domain expertise and the ability to operate independently while driving high-impact innovation. The successful candidate will lead product and technology development initiatives, collaborate across disciplines, and apply their expertise to sustain and improve on market Oncology assays. A strong understanding of NGS, product development, and desire to problem solve is essential.

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