Senior Scientist, IVD Test Dev. at Cleveland Diagnostics

Cleveland, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Jun, 26

Salary

140000.0

Posted On

12 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IVD Test Development, Assay Development, Assay Validation, Design Control, Regulatory Submissions, PMA, 510(k), IVDR, Experimental Design, Data Analysis, Statistical Analysis, Quality Management System, Technical Documentation, CLSI Standards, Analytical Validation, JMP

Industry

Biotechnology Research

Description

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 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 (

Responsibilities

This role involves leading and owning complex in-vitro diagnostic assay development and validation programs within a regulated environment, driving innovation from concept through regulatory submission. The scientist will define validation strategies, oversee study execution under the quality system, interpret complex data, and author necessary technical documentation.