Senior Scientist – IVD Consumables Product Development

Organization
Illumina
Job Location
5200 Illumina Way
San Diego, CA 92122
Salary
Competitive Base Salary + Bonus + RSU Equity
Job Description

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

This Senior Scientist will work in a dynamic, team-oriented environment to develop robust, scalable manufacturing processes for consumables used in cutting-edge genomics research and for clinical applications. This Scientist will have experience with consumables in a product development setting, as well as deep technical knowledge in surface chemistry and fabrication. You will participate in the development and optimization of high-throughput IVD or molecular biology assays which will serve to accelerate next generation sequencing.

Responsibilities

  • Cross functional collaboration with Engineering, Molecular Biology, Quality and Production to develop new processes for consumables products used in Illumina’s NGS platforms (flow cells, microarrays & digital fluidics cartridges)
  • Help to establish best practices for consumables product development in compliance with quality system regulations
  • Define technical requirements for consumable products in consideration of manufacturing robustness, scalability and cost
  • Construct and execute controlled experiments (including DOEs) to optimize processes to achieve commercial levels of stability, robustness, and performance
  • Use systematic problem-solving methods to troubleshoot complex issues related to product quality, stability and robustness
  • Provide technical leadership in the transfer of new processes and products to production
  • Be both a strong individual contributor as well as a collaborative team member

 

Requirements

Required Skills & Experience

  • PhD in Chemistry, Biochemistry, Materials Science, Physical Chemistry, Chemical Engineering, or Biochemical Engineering or closely related discipline
  • 7+ years’ industry experience in new product development with emphasis on consumables
  • 2 or more years’ experience in commercial IVD or molecular diagnostics product development for regulated markets
  • Strong background in surface chemistry and fabrication
  • Working knowledge of ISO13485, 21 CFR Part 11, ISO9001 and QSR guidelines required
  • Solid experience with process development, improvement, scale-up and transfer to manufacturing
  • Strong data analysis skills, ability to interpret and draw conclusions from large amounts of data
  • Experience with design of experiment (DOE) methodologies and statistical methods for large dataset analysis (i.e., JMP, etc.)

 

Preferred Skills & Experience

  • Strong technical science knowledge around glass fabrication, MEMs, nano-fabrication
  • Experience with fabrication, coating and/or electro-wetting processes
  • Large scale experience around sequencing flow cells
  • Domain expertise in DNA sequencing development
  • Experience with transfer of new products to manufacturing and/or QC desired
About Our Organization

About Illumina

Illumina is improving human health by unlocking the power of the genome.  If that inspires you, let’s talk. Having built a culture fueled by innovation, collaboration and openness, we’ve established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue; we’ve been hiring the best and the brightest. That’s why MIT ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.

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