Senior Scientist - Functional MDT

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Position Summary:

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.

The estimated base salary range for the Senior Scientist - Functional MDT role based in the United States of America is: $98,400 - $147,600. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.