Title: Senior Associate Scientist, IVD Test Development

Location: On-site, Cleveland, Ohio

Reports to: Sr Director, IVD Test Development

Job Description: The Senior Associate Scientist will support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. This role requires strong hands-on technical skills, attention to detail, and the ability to follow established protocols while contributing to experimental planning and troubleshooting under the guidance of a supervisor.

• In collaboration with a supervisor, design and plan laboratory experiments with clearly defined objectives and success criteria.
• Independently execute laboratory experiments supporting assay development, optimization, verification, and validation in accordance with approved protocols and design control requirements.
• Provide technical input toward refinement of new diagnostic assays and improvements to existing assay workflows.
• Independently apply basic to intermediate statistical analyses to study results and ensure data accuracy and integrity.
• Prepare data summaries, figures, tables, and preliminary interpretations for internal technical review.
• Maintain complete, accurate, and GDP/QMS-compliant experimental records and documentation.
• Perform routine troubleshooting of assays, instrumentation, and laboratory workflows; escalate complex issues appropriately.
• Prepare reagents, solutions, and study materials while ensuring traceability and proper documentation.
• Demonstrate accountability for assigned workstreams, meeting study timelines, documentation standards, and data quality expectations.
• Coordinate with vendors and internal teams to procure laboratory supplies and maintain operational readiness.
• Actively participate in technical discussions, team meetings, and cross-functional reviews.
• Ensure compliance with all safety policies, biosafety procedures, laboratory standards, and company requirements.
• Other duties as assigned

• 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

• 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
• May require infrequent travel
• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)

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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.