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Staff Scientist

| South San Francisco, CA

(Some remote work options)

The Robinson Group is partnering with a global, Fortune 100 company at the forefront of the life sciences industry.

They are looking for a Staff Scientist who wants to be a major driver in impacting patient’s lives.

Very competitive salary, bonus and benefits with great work/life balance.

Employee-centric company open to relocation and visa transfer.

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.

Responsibilities:

  • 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

Education/Experience:

  • 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
  • Max. file size: 300 MB.

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