We are seeking a highly skilled Scientist, IVD Test Development to contribute to in-vitro diagnostic (IVD) assay development and validation efforts within a regulated environment operating under design control. The successful candidate will independently design and execute experiments to support assay optimization, verification, and validation activities for regulatory submissions including PMA, 510(k), and IVDR. Title: Scientist, IVD Test Development Location: On-site, Cleveland, Ohio Reports to: Sr Director, IVD Test Development Job Description: The Scientist will contribute to in-vitro diagnostic (IVD) assay development and validation efforts within a regulated environment operating under design control, working independently design and execute experiments to support assay optimization, verification, and validation activities for regulatory submissions including PMA, 510(k), and IVDR.
The Scientist role requires strong technical expertise in assay development, data analysis, and troubleshooting, with the ability to manage defined project workstreams and timelines while collaborating cross-functionally with R&D, Quality, Regulatory, and Manufacturing teams.
In addition to hands-on laboratory responsibilities, this position is expected to provide technical guidance to junior team members and support method transfers and process improvements. The role may also involve handling human biological specimens such as blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies. Essential Duties and Responsibilities - Plan and lead the design, execution, and analysis of assay optimization and validation studies with minimal supervision, including assessment of method limitations and risk.
- Author study protocols and reports to support regulatory submissions.
- Apply intermediate to advanced statistical analyses to evaluate assay performance, interpret results, and draw scientifically sound conclusions.
- Prepare high-quality data packages, figures, tables, and integrated interpretations suitable for internal decision-making.
- Ensure complete, accurate, and GDP/QMS-compliant experimental documentation.
- Lead troubleshooting efforts for assay, instrumentation, or workflow challenges
- Take ownership of defined workstreams within the product development process, including scientific quality, timelines, risk management, and deliverables.
- Contribute to the development, review, and continuous improvement of SOPs, work instructions, and training materials.
- Actively participate in cross-functional analytical discussions, design reviews, and project team meetings as a scientific contributor.
- Champion laboratory safety, quality, and compliance culture; ensure adherence to all safety policies, laboratory procedures, and company standards
- Other duties as assigned
Qualifications/Requirements -
Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 8-12 years of relevant experience. -
Master’s degree with 4-8 years of experience -
Ph.D. with 0-2 years of experience Technical Skills: -
Extensive technical expertise in product development -
Strong working knowledge of CLSI standards and demonstrated ability to translate guideline requirements into statistically sound study protocols and reports. -
Experienced at creating formal protocols and reports -
Extensive experience optimizing and troubleshooting assays during development -
Experience with statistical analysis software (Analyze-It, JMP) -
Proficient computer skills especially with Microsoft Office applications -
Commercial IVD product development experience preferred 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 (<10%)
- Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)
------------------------------------------------------ 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 offers an extremely robust benefits package which includes: - 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
- 100% Employer-paid Dental & Vision for entire family
- No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
- 4% retirement contribution Employer match
- Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
- Paid Family Leave Program
- Generous PTO plan & holiday program
- Flexible work schedule & lucrative employee referral program
- Salary range may vary by work state/geographical region/territory
- Easy to get to office location with newly built-out office space
- Free coffee, snacks and other goodies all day long
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.
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