Senior Scientist-IVD Test Development

Cleveland Diagnostics; Cleveland (OH); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Scientist for IVD Test Development to lead innovative research projects. This role requires extensive expertise in in vitro diagnostics, managing product validation studies, and ensuring compliance with regulatory standards. The successful candidate will mentor junior scientists, execute complex statistical analyses, and prepare professional reports for regulatory submissions. Join a dynamic team dedicated to advancing diagnostic technology in a collaborative environment that values scientific excellence and innovation.

Benefits

Comprehensive benefits

Dynamic work environment

Diversity and inclusion initiatives

Qualifications

• 16-20 years of experience in IVD assay development.
• Ability to lead research teams and manage multiple projects.
• Strong understanding of FDA and global regulatory requirements.

Responsibilities

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

Skills

IVD product development

Statistical analysis

Regulatory submission protocols

Project management

Mentorship

Data interpretation

Education

Bachelor's degree in Biology or related field

Master's degree

Ph.D.

Tools

Analyze-It

JMP

Job description

Join to apply for the Senior Scientist-IVD Test Development role at Cleveland Diagnostics.

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

Position Details

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 degree with 10-15 years of experience
• Ph.D. with 7-12 years of experience
• Technical Skills:
• Extensive technical and managerial expertise in IVD product development
• Experience creating protocols and reports suitable for regulatory submission
• Strong understanding of FDA and global regulatory requirements
• Experience with statistical analysis software (Analyze-It, JMP)
• Commercial IVD product development experience preferred
• Leadership & Analytical Skills:
• Ability to lead research teams and manage multiple projects effectively
• Strong data analysis and statistical interpretation skills
• Ability to troubleshoot complex technical issues and drive problem-solving initiatives
• Communication & Collaboration:
• Proven ability to develop high-impact scientific reports, publications, and presentations
• Excellent verbal and written communication skills, with experience presenting to diverse audiences
• Strong interpersonal skills for mentorship and cross-functional collaboration

Physical Requirements & Working Conditions

• Fine motor skills and manual dexterity to handle specimens and lab equipment
• Visual acuity to examine specimens and reagents
• Office accessibility and ability to climb stairs if needed
• Light lifting (up to 25 pounds)
• Ability to stand for long periods
• Proficiency with computers and lab equipment
• Ability to work with hazardous chemicals and biohazards following PPE requirements
• General office and noise environment

Other Requirements

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

Cleveland Diagnostics is dedicated to fostering a diverse and inclusive workplace. We offer comprehensive benefits and a dynamic work environment. If you are passionate about advancing diagnostic technology and making a difference, we encourage you to apply.