Senior Scientist – IVD Test Development

Scientific Search; Cleveland (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative diagnostics firm is seeking a Senior Scientist to spearhead the development of non-invasive cancer tests. In this pivotal role, you will lead complex assay validation projects that support regulatory submissions while mentoring junior scientists. Your expertise will help shape the future of diagnostics for prostate, breast, and lung cancer. This is an exciting opportunity to work in a newly renovated office with a vibrant atmosphere, where you will contribute to advancing transformative healthcare solutions. If you are passionate about making a difference in the field of diagnostics, we want to hear from you!

Benefits

100% employer-paid medical

Dental & vision for family

Stock options

4% 401(k) match

Paid parental leave

Flexible schedule

Newly renovated office

Coffee and snacks

Qualifications

• PhD with 7–12 years or MS with 10–15 years in IVD product development.
• Strong knowledge of FDA and global regulatory standards.

Responsibilities

• Lead validation studies and develop protocols per regulatory standards.
• Prepare and present technical reports and regulatory documents.

Skills

Statistical analysis

Project management

Communication skills

Assay development

Regulatory knowledge

Education

PhD in relevant field

MS in relevant field

BS in relevant field

Tools

JMP

Analyze-It

Job description

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 [e-mail] and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19290.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Biotechnology