Job Description

Scientist/Senior Scientist - In Vitro Diagnostics (IVD) Test Development

Onsite - Cleveland

Senior Director, IVD Test Development

A growing team is looking for a Scientist/ Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead research projects, contribute to scientific innovation, and oversee Validation & Verification studies supporting PMA, 510K, and IVDR approvals . This position requires working within a regulated environment under design control , managing project timelines, analyzing data, and mentoring junior scientists. Additionally, the role may involve handling human biological specimens (blood, plasma, urine, and other bodily fluids) while ensuring compliance with safety regulations and organizational policies.

• Oversee project studies that contribute to regulatory filings while effectively managing multiple unrelated projects.
• Design and refine study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory standards.
• Execute and document product development activities in alignment with design control procedures and quality management systems .
• Independently perform statistical analyses or collaborate with statisticians to evaluate data.
• Analyze and interpret experimental results, providing insights and determining next steps for project advancement.
• Ensure data accuracy and validity for internal reports, regulatory submissions, and scientific publications.
• Prepare comprehensive and well-structured study reports for regulatory documentation.
• Develop and deliver data-driven presentations to internal teams and external stakeholders.
• Lead technical discussions, drive project meetings, and ensure strategic alignment with company goals.
• Supervise and mentor junior scientists, fostering a culture of innovation and scientific excellence .
• Maintain compliance with safety guidelines , including biosafety and hazardous material handling protocols.
• Perform other duties as required.

Education & Experience:

• Ph.D. in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 7-12 years of industry experience .
• Master's degree with 10-15 years of relevant experience .
• Bachelor's degree with 16-20 years of experience .

Technical Expertise:

• Extensive experience in IVD product development , with strong knowledge of FDA and global regulatory requirements .
• Hands-on experience creating protocols and reports suitable for regulatory submission.
• Proficiency in statistical analysis software (Analyze-It, JMP).
• Experience in commercial IVD product development is preferred.

Leadership & Analytical Abilities:

• Demonstrated ability to lead research teams and effectively manage multiple projects.
• Strong analytical and problem-solving skills , with expertise in data interpretation and statistical analysis .
• Ability to troubleshoot complex technical challenges and drive research forward.

Communication & Collaboration:

• Proven experience in developing high-quality scientific reports, publications, and presentations .
• Excellent verbal and written communication skills , with confidence in presenting findings to diverse audiences.
• Strong interpersonal skills for mentorship and cross-functional collaboration .

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