Senior Scientist - Functional MDT

Illumina•San Diego, CA

About The Position

We are looking for a driven, talented Senior Scientist to join our Functional Method Development & Transfer (MDT) team. Functional MDT is a center of excellence (COE) for functional test method development, qualification/validation, and transfer that supports new product introduction (NPI), early access releases, cost savings, and on-market investigations. This role is a highly collaborative, hands-on position that partners cross-functionally with R&D/Development, Quality, Production/Manufacturing, Ops, and engineering groups to ensure robust, compliant, and seamless transfer of test methods into QC/production environments.

Requirements

Ability to communicate effectively and build strong relationships across multiple departments.
Ability to work in fast-paced environment; easily adaptable to changing priorities.
Experience in a wide-variety of molecular biology methods for nucleic acid analysis and manipulation including DNA and RNA purification, amplification, labeling, hybridization, etc.
Experience with next generation sequencing technologies.
Experimentation & statistics: DOE mindset, measurement systems thinking (gauge R&R), data trending, and evidence-based recommendations.
Transfer execution excellence: protocol-driven execution, acceptance criteria, readiness checks,
Be a highly competent investigator, able to troubleshoot and quickly solve challenges
Solid understanding of DNA and RNA preparation techniques.
Demonstrate capability to support the process and/or test methods development activities.

Nice To Haves

Experience with automation and data analysis tools highly desired.
Experience in editing or troubleshooting automation methods/workflows
Knowledgeable of electronic change management and document management systems; knowledgeable of ERP/MRP systems.
Knowledgeable of ISO 13485, ISO 147901, 21 CFR 820 / 11, or other regulatory requirements and its application

Responsibilities

Lead functional method development, optimization, and transfer activities for complex biological workflows (e.g., sequencing/workflow-based functional assays used for QC release and investigations).
Design and execute controlled experiments (including DOEs and gauge R&R studies) to develop/optimize manufacturing- and QC-ready workflows and test methods.
Plan and execute method qualification/validation activities and ensure documentation/data packages meet applicable requirements for regulated environments.
Own and drive end-to-end transfer readiness: method transfer deliverables, QC onboarding, training, and transfer communications (e.g., transfer packages, checklists, and transfer presentations
Provide technical leadership for QC equipment and software onboarding/validation needed to execute functional workflows and enable QC-ready results reporting.
Collect, analyze, interpret, and review test data, perform primary technical review, and generate/approve technical reports and documents (protocols, reports, WIs, troubleshooting guides) per good documentation practices.
Partner cross-functionally as a liaison between development and manufacturing/QC teams; influence technical direction, align stakeholders, and unblock transfer risks
Mentor and develop others (Scientists/Associates); set technical standards and best practices for functional method development and transfer execution.