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Job ID :
62093BR
Location :
US - California - Carlsbad
:
Job Description

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.

Division Specific Information

The Clinical Next-Generation Sequencing business, part of our Life Sciences Solutions group. Personalized precision
medicine has become a new paradigm in oncology treatment, offering hope for improved cancer treatments. Advances in next-generation sequencing (NGS) allow clinicians and laboratory professionals to routinely gather therapy-relevant molecular information in a timely fashion, a prerequisite for true personalized medicine in the face of a growing list of molecularly targeted drugs.

The Clinical Next-Generation Sequencing Division (CSD) offers multiple solutions for solid tumor biomarker testing to aid in identifying those patients eligible for treatment, based on Ion Torrent and Oncomine NGS technology.

How will you make an impact?

We are seeking a Staff Scientist, Bioinformatics to join our R&D team for development of next generation sequencing assays for use in clinical laboratories.

Candidates will contribute to:

  • Verification and Validation Studies in preparation for a PMA submission to the FDA
  • Diagnostic assays that comply with regulatory standards such as FDA and CE Marking
  • Data management across internal and external sites
What will you do?
  • Lead all the data analysis effort for verification and validation studies to be submitted to FDA
  • Work with CRO and external sites to co-ordinate data analysis, data archiving, and data management
  • Prepare documents for FDA submission
  • Interface between molecular biology and software team to clearly outline software design
  • Support development of QC specifications for reagent release at manufacturing sites
  • Support server and instrument maintenance and software upgrade
  • Work with team members in a collaborative environment
  • Will need to maintain complete and thorough documentation required to meet QSR Design Control, as well as other international standards (e.g., ISO compliance, GLP/GMP requirements, etc.).
  • Needs to be self-motivated, capable of multi-tasking and able to ensure focused and timely execution of projects.
  • The candidate will work in a fast paced environment with supportive teammates
  • Actively participate in the team with a positive and proactive attitude
How will you get here?
Education:
  • M.S. with at least 3-4 years of experience in an academic or industrial laboratory or Ph.D with 1-2 years’ experience in an academic or industrial laboratory
Experience:
  • Experience in Next Generation Sequencing (NGS)
  • Bioinformatics experience
  • Experience with Ion Torrent mapping, variant calling and fusion detection algorithms
  • Experience in perl/python scripting
  • Experience in Java Programming
  • Experience in IVD software product development, is a plus
  • Must be tolerant to change, ready to take on new challenges and open to learning new skills, anticipate needs and problems, while creating solutions.
Knowledge, Skills, Abilities:
  • Basic understanding or working knowledge of software testing preferred
  • Excellent communication skills, both written and oral
At Thermo Fisher Scientific, each one of our 65,000 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.

Apply today! http://jobs.thermofisher.com
*IND-LSG


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.
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