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Staff Scientist - IVD Product Development

Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: July 14, 2021

Job Description:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

How will you make an impact?

The Genetic Testing Solutions group is a team of passionate individuals who are deeply committed to making the world healthier through development of molecular diagnostics. This role will be responsible for leading projects to develop and commercialize molecular assay products for both research and clinical applications on Thermo Fisher Scientific sample-to-answer platforms.

This is an opportunity for a highly motivated IVD scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine. The ideal candidate will be a strong team player who is passionate about delivering high quality simple, effective, customer-focused products. The successful candidate will incorporate IVD and molecular biology experience to develop robust, innovative diagnostics.

What will you do?

  • This is a hands-on lab position, including mentorship and project lead responsibilities
  • Collaborates with cross functional core teams
  • Plans and executes IVD development experiments, from proof of concept to validation, regulatory submission and launch
  • Actively participates as a member of cross-functional product development teams
  • Leads data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods
  • Ensures products are adequately developed to enable smooth Design Transfer
  • Documentation under design control to ensure quality product development

How will you get there?

  • PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering with at least 5 years of biotech experience
  • Developed and launched commercial qPCR Assays
  • Demonstrated teamwork under tight timelines
  • Strong experience in IVD product development, following ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971
  • Have submitted 510k/PMA and / or List A CE-IVDD (or List D IVDR)
  • Design Control & Change control, and experience writing design quality records
  • Expertise in Process Capability / Six Sigma
  • Experience participating in audits
  • Demonstrates passion for problem solving and outside-the-box thinking
  • Demonstrates passion for mentoring and team development
  • Strong communication and presentation skills are essential
  • Must be highly collaborative and always willing to help others
  • Self-motivated, independent, proactive, organized, diligent, and very nimble

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit

Keywords: Thermo Fisher Scientific, South San Francisco , Staff Scientist - IVD Product Development, Other , South San Francisco, California

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