Cleveland Diagnostics has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform to develop novel diagnostics based on protein structure-based assessment.

Industry: Biotechnology Research
Company Size: 51-200 employees

Cleveland Diagnostics

Savvy Admin PROD

**Senior Scientist, IVD Test Dev. **

We are seeking a highly skilled **Senior Scientist, IVD Test Development t **o 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 stand for long periods of time

- Ability to operate a computer and other technology related lab equipment through course of day

- Ability to work in an environment with exposure to hazardous chemicals and biohazards

- Ability to comply with all appropriate job PPE requirements

- General office and HVAC noise

**Other Requirements **

- Full-time on-site position; this is not a remote position

- This position is classified as exempt and may require work in excess of 8 hours per day and/or 40 hours per week as business needs dictate

- This position may require occasional travel (

Senior Scientist, IVD Test Dev.

Qnity™ is the name of DuPont's Electronics business, providing solutions to the semiconductor and electronics industries.

Industry: Semiconductor Manufacturing
Company Size: 10,001+ employees

Qnity

**Are you looking to power the next leap in the exciting world of advanced electronics? **Do you want to help solve problems that drive success in the rapidly evolving technology and connectivity landscape? Then bring your problem-solving, passion, and creativity to help us power the next leap in electronics.

At **Qnity **, we’re more than a global leader in materials and solutions for advanced electronics and high-tech industries – we’re a tight-knit team that is motivated by new possibilities, and always up for a challenge. All our dedicated teams contribute to making cutting-edge technology possible. We value forward-thinking challengers, boundary-pushers, and diverse perspectives across all our departments, because we know we play a critical role in the world enabling faster progress for all. Learn how you can start or jumpstart your career with us.

**Key Responsibilities**

- Perform theoretical and experimental research directed toward the acquisition of new scientific and technological knowledge.

- Conduct analytical, experimental, investigative, and fact-finding activities to support principal research initiatives.

- Prepare thorough documentation of research outcomes, including observations, analyses, interpretations, technical reports, summaries, protocols, and quantitative analyses.

- Identify, assess, and develop new scientific concepts, technologies, or methodologies in basic or applied research with business relevance.

- Document and communicate research results that contribute to patent disclosures and/or technical and scientific advancement.

- Lead or support technical projects or programs through development and implementation, as appropriate for role scope and experience.

**Preferred Experience**

- Experience with phase-transition heat transfer technologies, such as heat pipes and vapor chambers, is a plus.

**Preferred Educational Experience: **Degree in Physics, Applied Physics, Mechanical Engineering, Materials Science, Chemical Engineering, or a related scientific or engineering discipline with coursework or research emphasis on bench‑top experimental science, thermodynamics, heat transfer, or applied physics.

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Qnity is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information.

Qnity offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page.

**We use Artificial Intelligence (AI) to enhance our recruitment process.**

Lead Scientist

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