Senior Scientist – Functional MDT Full-time

Senior Scientist – Functional Method Development & Transfer

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 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.

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.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

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. Experience with automation and data analysis tools highly desired.
• 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.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

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

Education / Experience:

B.S./M.S. in Biochemistry, Chemistry, Biological Sciences, Physical Chemistry or equivalent disciplines with 6+ years of experience.