Senior Staff Scientist

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.

The Sr Staff Scientist will work on the development and validation of clinical diagnostic products in the Illumina Laboratory Services (ILS) group located in San Diego, California. The primary function of this position will be to drive assay development and assay validation efforts of our clinical diagnostic pipeline(s) in a CLIA certified laboratory environment. The candidate will lead multi-disciplinary investigation and resolution of technical problems, have experience interfacing with cross functional teams within and outside of ILS. The candidate will be required to have hands-on wet lab experience and broad knowledge in NGS sequencing (Illumina platforms) and molecular biology methods for nucleic acid applications. This position will require some laboratory work and oversee junior scientists.

Responsibilities:

• Lead assay wet-lab development and validation efforts in CLIA, CAP and ISO13485 compliant environment.
• Design and execution of experiments to support process development, validation, and ongoing improvements.
• Ability to apply design of experiment (DOE) methods, and collect requirements, plan activities, and contribute to budget of allocated project scope, and prioritization of activities/assignments to supporting team members.
• Able to identify risk and provide recommendations for risk mitigation in area of responsibility and at project level.
• Ability to deeply collaborate with SMEs cross-functionally and help narrow down the scope of the projects.
• Able to own a large subsystem or workflow with no oversight.
• Supports Clinical laboratory and product development processes.
• Analyzes data and write development and validation reports.
• Be a technical and integration representative for Operations on cross functional initiatives.
• Works closely with scientific, bioinformatics, engineering, software and commercial teams to develop, validate, and transfer new products into the Clinical laboratory.
• Supports and troubleshoots existing processes and provides guidance on potential enhancements.

Requirements:

• PhD in Molecular Biology, Genomics, Genetics, or Biochemistry with 5+ years of regulated industry experience (CLIA/CAP/NYSDOH) in clinical assay development and assay validation (IVD, LDT, and/or CDx).
• Strong knowledge and hands-on experience using NGS technology (Illumina platform) with emphasis in Oncology and clinical Whole Genome Sequencing applications.
• Strong statistical background for study design, DOE, data analysis, process monitoring and QC.
• Communication skills and ability to implement technologies developed from R&D and product development into a CLIA environment.
• Able to create requirements, plan activities and contribute to risk assessment at the interface of multiple project teams, and prioritize activities/assignments to supporting team members.
• Ability to set technical goals for product roadmaps.
• Able to manage vendors and contractors on a technical and tactical business level.
• Ability to lead technical collaborations and make technical sound decisions.
• Ability to think innovatively toward solving problems effectively and efficiently.
• Adept inter-personal skills to contribute to cross functional project teams and work with stakeholders.
• Experience with project management and good documentation practices

The estimated base salary range for the Senior Staff Scientist role based in the United States of America is: $138,800 - $208,200. 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