Close Menu

Scientist III, IVD Product Development

Organization
Thermo Fisher Scientific
Job Location
180 Oyster Point Blvd
South San Francisco, CA 94080
United States
Job Description

Scientist III, IVD Product Development
Requisition ID: 121086BR
South San Francisco, CA

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 Sciences Division is seeking an experienced and highly motivated Development Scientist to work on a team developing qPCR based microbial detection applications for regulated markets. The candidate will have a strong understanding of regulated product development (CE-IVD or US IVD) and QSR systems, a broad understanding of molecular biology and/or biotechnology, strong writing skills, and the ability to collaborate effectively as part of a cross functional team including R&D, Software, Product Managers, Manufacturing and external partners

What will you do?

  • Write protocols and reports required for development of regulated products
  • Provide technical guidance during interactions with US FDA and other regulatory bodies
  • Develop plans to ensure laboratories meet ISO 13485 regulations
  • Transfer new qPCR products and processes to Manufacturing.
  • Support product launch activities and perform on-market product and manufacturing troubleshooting with strong “customer-first” mind set
  • Design experiments required for development and validation of products
Requirements

How will you get here?
Education
BA/BS Degree, 5+ years/ MS Degree, 3+ years/ PhD Degree, 2+ years of industry experience

Experience

  • Strong skills in molecular biology (including DNA, RNA and protein handling, PCR, qPCR, quantification methods)
  • Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
  • Understanding of Quality Systems Regulations and cGMP product development
  • Knowledge of basic data analysis and interpretation (proficient in Microsoft Office)

Knowledge, Skills, Abilities

  • Driven to deliver quality results on time and in a highly ethical and professional manner
  • Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective
  • Must be tolerant to change, ready to take on new challenges and open to learning new skills

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer. At Thermo Fisher Scientific, each one of our 75,000 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. For more information, please visit www.thermofisher.com.

 

Science reports that faculty members are concerned about the risks reopening universities during the coronavirus pandemic pose.

Inside Higher Ed reports faculty members want a say in re-opening discussions.

Inside Higher Ed reports the Centers for Disease Control and Prevention has recommendations for how universities could keep students safe if they return to campus.

At Nature Careers, a postdoc gives advice for graduate students who have to do their PhD defenses remotely.