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Posted 2 days ago
Staff Scientist - Oncology On Market Support and Development
IlluminaStaff Scientist - Oncology On Market Support and Development
Requirements
PhD in biochemistry, molecular biology, genetics, genomics, or bioengineering with 3+ years experience, MS with 6+ years experience, BS with 8+ years experience, Experience with clinical diagnostic device product development, Knowledge of design controls and risk management, Strong project management and cross-functional leadership skills
Skills
Molecular BiologyNGSproduct development
About the role
Responsibilities
- Lead and execute large-scale technical and product development projects for TruSight Oncology assays, including activity planning and requirement definition.
- Manage individual project workstreams independently, ensuring deliverables meet commercial standards for stability and performance.
- Collaborate cross-functionally with Scientists, Engineers, Bioinformaticians, Quality, and Manufacturing teams to optimize assay conditions and QC processes.
- Apply Product Development Processes (PDP) and Quality Management Systems (QMS) to maintain regulatory compliance.
- Lead risk analysis and FMEA activities for project teams.
- Mentor junior scientists and engineers, delegating sub-tasks and providing technical guidance.
- Partner with Marketing and Regulatory stakeholders to support communications to customers and the field.
Requirements
- PhD in biochemistry, molecular biology, genetics, genomics, or bioengineering with 3+ years of experience (MS with 6+ years, or BS with 8+ years).
- Experience in the development, verification, validation, and regulatory submission of clinical diagnostic devices for regulated markets.
- Demonstrated knowledge of design controls and risk management.
- Proven ability to lead project subfunctions, including technical planning and milestone tracking.
- Strong project management skills and the ability to drive both new product development and improvements for on-market products.
- Excellent communication skills for working in fast-paced, multidisciplinary environments.
Preferred Qualifications
- Experience with the transfer of new products to manufacturing and/or Quality Control (QC).
- Deep domain expertise in Next-Generation Sequencing (NGS) and molecular biology.
Benefits
- Competitive base salary range ($118,200 - $177,200).
- Eligibility for variable cash programs (bonus or commission) and potential equity.
- Comprehensive health, dental, and vision insurance.
- Retirement benefits and paid time off.
- Access to genomics sequencing and family planning support.
About the Company
Illumina is a global leader in genomics, expanding access to genomic technology to realize health equity for billions of people. Our innovations enable life-changing discoveries in disease detection, diagnosis, and treatment, transforming human health through the power of the genome.
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Get started — it's freeStaff Scientist - Oncology On Market Support and Development
Illumina · San Diego
