Senior Scientist-IVD Test Development

Society for Conservation Biology; Bratenahl (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in cancer diagnostics seeks a Senior Scientist for IVD Test Development. The role involves leading research projects, managing product validation, and mentoring junior scientists. Candidates should have extensive experience in IVD development and regulatory compliance. This full-time position is based in Cleveland with a comprehensive benefits package.

Benefits

Comprehensive benefits package

Supportive workplace

Flexible workplace

Qualifications

• 16-20 years of relevant experience with Bachelor's; 10-15 years with Master's; 7-12 years with Ph.D.
• Extensive expertise in IVD product development and regulatory submissions.

Responsibilities

• Lead project studies supporting regulatory filings on multiple projects.
• Train and mentor junior scientists.
• Prepare study reports for regulatory submissions.

Skills

Leadership

Analytical Skills

Communication

Education

Bachelor's degree in Biology

Master's degree

Ph.D.

Tools

Analyze-It

JMP

Job description

Our team is growing, and we currently have an immediate opening for a Senior Scientist- IVD Test Development.

Title

Senior Scientist-IVD Test Development

Location

Onsite-Cleveland Office

Reports To

Sr Director, IVD Test Development

Job Overview

We are seeking a highly skilled Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead complex research projects and drive scientific innovation. The successful candidate will manage product Validation & Verification studies supporting PMA, 510K, and IVDR approval, working in a regulated environment under design control. This role involves project timeline management, data interpretation, and mentorship of junior scientists. The position may also require handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.

Essential Duties & Responsibilities

• Lead project studies supporting regulatory filings, working on multiple unrelated projects simultaneously
• Train and mentor junior scientists, fostering a culture of scientific excellence
• Execute and document product development work under design control and the company's quality management systems, policies, and procedures
• Develop and optimize study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory agency requirements
• Perform complex statistical analyses independently or in coordination with statisticians
• Interpret experimental results, draw conclusions, and define next steps to achieve project objectives
• Ensure analyses and result interpretation are accurate and appropriate to support internal reports, regulatory submissions, and scientific publications
• Prepare clear, concise, and professional study reports to support regulatory submissions
• Develop and deliver data-driven presentations for internal and external stakeholders
• Create presentations to effectively communicate key research findings and project status
• Lead technical discussions and project meetings, ensuring alignment with strategic goals
• Ensure compliance with all safety and company policies, including biosafety and hazardous material handling protocols
• Perform all other duties as assigned

Qualifications

• Education & Experience: Bachelor's degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 16-20 years of relevant experience; Master's with 10-15 years; Ph.D. with 7-12 years
• Technical Skills: Extensive expertise in IVD product development, creating protocols and reports for regulatory submission, understanding FDA and global regulatory requirements, experience with statistical analysis software (Analyze-It, JMP), and preferred experience with commercial IVD products
• Leadership & Analytical Skills: Proven ability to lead research teams, manage multiple projects, and analyze data effectively
• Communication & Collaboration: Ability to develop scientific reports, publications, presentations, and communicate effectively with diverse audiences

Physical Requirements & Working Conditions

• Manual dexterity, visual acuity, ability to lift up to 25 pounds, stand for long periods, and operate lab equipment and computers
• Exposure to hazardous chemicals and biohazards, with adherence to PPE requirements

Other Requirements

• COVID-19 vaccination recommended
• Full-time on-site position; occasional travel may be required

Cleveland Diagnostics, Inc. develops innovative, affordable cancer diagnostics. We offer a comprehensive benefits package and foster a supportive, flexible workplace. We are an equal opportunity employer committed to diversity and inclusion.