Senior IVD Test Development Scientist

Cleveland Diagnostics Inc.; Cleveland (OH); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

100% Employer‑paid medical for single,

100% Employer‑paid Dental & Vision for

4% retirement contribution Employer

Promotion/Performance Pay, Incentive &

Paid Family Leave Program and more

Résumé du poste

Cleveland Diagnostics seeks a Senior Associate Scientist for IVD Test Development to drive assay development, verification and validation in a regulated setting. You will execute experiments, analyze data, and contribute to regulatory submissions while ensuring quality documentation and adherence to design control.

The role involves hands-on laboratory work with human-derived specimens, collaboration across teams, and continuous improvement initiatives to support internal clinical lab use and

Qualifications

• Bachelor’s degree in biology, biochemistry, molecular biology, or related field with 2–4 years of experience.
• Master’s degree with 1–2 years of experience.
• Industry experience is preferred.

Responsabilités

• Design and plan laboratory experiments with clearly defined objectives and success criteria.
• Independently execute experiments supporting assay development and validation per protocols and design control requirements.
• Prepare data summaries, figures, tables, and interpretations for internal technical review.
• Maintain accurate, GDP/QMS-compliant documentation and records.
• Coordinate with vendors and teams to procure lab supplies and ensure readiness.

Connaissances

Laboratory techniques

Data analysis

Troubleshooting

Regulatory compliance

Statistical analysis

Documentation

Formation

Bachelor’s degree in biology/biochemistry/molecular biology

Master’s degree with 1–2 years of experience

Outils

Immunochemistry analyzers

Excel

QMS documentation systems

Description du poste

Cleveland Diagnostics seeks a Senior Associate Scientist for IVD Test Development to drive assay development, verification and validation in a regulated setting. You will execute experiments, analyze data, and contribute to regulatory submissions while ensuring quality documentation and adherence to design control.

The role involves hands-on laboratory work with human-derived specimens, collaboration across teams, and continuous improvement initiatives to support internal clinical lab use and