23 days old

Staff Scientist, IVD Process Development

California City, CA 93505
Location :
US - California - South San Francisco
Job Description
Staff Scientist, IVD Process Development
Requisition ID: 106296BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

US- South San Francisco, CA
IVD Process Development (Genetic Sciences Division)

How will you make an impact?
You will have leadership responsibility in planning and oversight for scientific activities in the research and development of in clinically oriented products. You will lead regulated product development for infectious diseases and work collaboratively with product management, hardware and software engineering, assay development, and manufacturing teams to take new IVD platforms and assays through concept, feasibility, development, and commercialization.

What will you do?
  • Work with a team of R&D scientists through all phases of product development with the design, development and validation of integrated automated systems under ISO13485
  • Demonstrate expertise with automated liquid handlers including programming/scripting and strong proficiency with method development including sample prep and assay integration on liquid handlers for the implementation of infectious disease workflows
  • Work with a team of assay integration scientists that coordinate with technical leader on concept to development transfer; works with tech leader and systems team to characterize automation dependencies and tolerances
  • Interact cross-functionally to define products, transfer new designs to manufacturing, and ensure on-time regulatory submissions
  • Perform experiments in molecular biology laboratories (including a BSL2 lab) on a continuous basis
  • Design and execute DOE studies and analyze data using JMP or comparable program. Summarize study designs and results in PowerPoint for presentation at group meetings.
  • Complete lab compliance activities (per ISO 13485 QMS regulations)
  • Work in a fast paced environment with supportive teammates
  • In addition, the candidate will actively participate in external communication with external partners and internal teams across the globe to develop products for infectious disease research & diagnostics.

How will you get here?

5+ years/ MS Degree, 3+ years of industry/academic experience, PhD with 0-3 years’ experience (CE-IVD or US IVD space)

  • Experience with developing US IVD and/or CE-IVD products is critical.
  • Expert in process and method development on automation platform(s) including the Hamilton systems and expertise in technologies including qPCR analysis
  • Expertise in sample prep, fluidics and diagnostic methods for infectious diseases
  • Experience in a technical leadership role in diagnostics research and development

Knowledge, Skills, Abilities
  • Ability to communicate effectively with multi-disciplinary teams
  • Entrepreneurial spirit
  • Ability to work with limited instruction
  • Ability to travel and work in a fast-paced organization

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


Posted: 2019-11-12 Expires: 2019-12-12

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Staff Scientist, IVD Process Development

California City, CA 93505
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