Senior Scientist, IVD Test Dev

We are seeking a highly skilled Senior Scientist, IVD Test Development to lead in-vitro diagnostic assay development and validation programs within a regulated environment operating under design control. The successful candidate will provide scientific and strategic leadership for complex projects, driving assay innovation and overseeing verification and validation activities in support of regulatory submissions including PMA, 510(k), and IVDR.

Title: Senior Scientist, IVD Test Development

Location: On-site, Cleveland, Ohio

Reports to: Sr Director, IVD Test Development

Job Description:

This role requires deep technical expertise in assay development, experimental design, and advanced data analysis, with responsibility for managing to cross-functional project timelines, technical risk mitigation, and study execution from concept through regulatory submission while collaborating cross-functionally with R&D, Quality, Regulatory, and Manufacturing teams. The Senior Scientist will define validation strategies, oversee study execution under the company's quality management system, interpret complex datasets, and author and approve technical documentation in compliance with applicable regulatory and quality standards.

In addition to hands-on laboratory oversight, this position will mentor and develop junior scientists, provide technical leadership across teams, and contribute to departmental strategy, process improvements, and long-term product development initiatives. This role may involve handling human biological specimens including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.

Essential Duties and Responsibilities

• Lead and own complex assay development and validation studies supporting regulatory filings across multiple projects or assay platforms.
• Define study objectives, validation strategies, experimental designs, and success criteria aligned with program goals and regulatory expectations.
• Develop, review, and approve study protocols ensuring scientific rigor and compliance with design control and regulatory agency requirements.
• Oversee execution of product development and validation activities within the company's quality management system.
• Perform or direct complex statistical analyses independently or in collaboration with statisticians.
• Critically interpret experimental data, draw scientifically sound and defensible conclusions, and define strategic next steps to advance programs.
• Identify technical and regulatory risks and proactively develop mitigation strategies to maintain project timelines and compliance.
• Author, review, and approve high-quality technical reports and validation documentation suitable for regulatory submission.
• Develop and deliver data-driven presentations for internal leadership and external stakeholders.
• Lead technical discussions, cross-functional project meetings, and scientific decision-making forums.
• Mentor and develop junior staff, setting expectations for scientific rigor, documentation quality, and regulatory compliance.
• Model and enforce compliance with all safety, biosafety, quality, and company policies.
• Other duties as assigned

Qualifications/Requirements

• 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 developing regulated IVD products

• Deep understanding of CLSI standards and demonstrated ability to design statistically robust analytical validation strategies (precision, linearity, method comparison, LoB/LoD/LoQ, interference, stability) aligned with regulatory expectations.

• Experienced at 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:

• Demonstrated 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/Equipment Used:

• Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation.
• Visual acuity to examine specimens and reagents
• Offices reachable by elevator but should be able to climb stairs if needed
• Light lifting may be required (up to 25 pounds)
• May be required to…