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3P BIOSOLUTIONS INC6 months ago

Development Scientist

$70,000–$90,000 year

Remote · Woodbridge, Virginia, United States or New York City, New York, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

The Development Scientist will design, develop, and validate IVD assays and materials. This role emphasizes strong technical expertise and collaboration, requiring knowledge of regulatory expectations in IVD product development.

Required Qualifications

  • Bachelor’s, Master’s or Ph.D. in Biology, Biochemistry, Molecular Biology, Chemistry, or related field.
  • 2–5+ years of experience in IVD product development or clinical diagnostics industry (IVD R&D preferred).
  • Strong laboratory skills in immunoassay development, molecular diagnostics, chemistry-based assays, or related areas.
  • Experience with design of experiments (DOE), statistical analysis, and method validation.
  • Working knowledge of regulatory standards for IVDs (CLSI, ISO 13485, FDA, IVDR a plus).
  • Excellent analytical, organizational, and documentation skills.
  • Ability to work collaboratively in a fast-paced environment while managing multiple priorities.

Desired Qualifications

  • Experience with LC-MS/MS, ELISA, or PCR platforms.
  • Hands-on reagent formulation, stability studies, or lyophilization knowledge.
  • Experience writing technical documents for regulatory submissions.
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$70k – $90k / yr

Development Scientist · 3P BIOSOLUTIONS INC

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