Senior Scientist – IVD Test Development

Location: Cleveland, OH (On-site only)

Join a growing diagnostics innovator leading the charge in non-invasive cancer testing. My client is seeking a Senior Scientist to lead complex assay development and validation projects supporting PMA, 510K, and IVDR submissions. You’ll play a pivotal role in shaping their IVD pipeline—from early development to regulatory filings—while mentoring junior scientists and owning end-to-end scientific studies.

Why You Should Apply

• Help advance transformational diagnostics for prostate, breast, and lung cancer
• 100% employer-paid medical for individuals + dental & vision for family
• Stock options, 4% 401(k) match, paid parental leave, flexible schedule
• Newly renovated office with coffee, snacks, and great energy
  
  

What You’ll Be Doing

• Lead validation/verification studies and develop protocols per CLSI and regulatory standards
• Manage project timelines and mentor junior scientists
• Conduct statistical analyses and ensure data integrity
• Prepare and present high-impact technical reports and regulatory documents
• Contribute to regulatory filings and internal decision-making
  
  

About You

• PhD with 7–12 years (or MS with 10–15 years / BS with 16–20 years) in IVD product development
• Proficiency in statistical tools like JMP or Analyze-It
• Skilled in managing multiple assay development projects
• Exceptional written and verbal communication skills
• Strong knowledge of FDA and global regulatory standards
  
  

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to [email protected] and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19290.