Website Cleveland Diagnostics Inc.
Cleveland Diagnostics Inc.
Company : Cleveland Diagnostics Inc.
Our team is growing, and we currently have an immediate opening for an Senior Scientist- IVD Test Development
Title
Senior Scientist-IVD Test Development
Location
Onsite-Cleveland Office
Reports To
Sr Director, IVD Test Development
Job Overview
We are seeking a highly skilled Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead complex research projects and drive scientific innovation. The successful candidate will manage product Validation & Verification studies supporting PMA, 510K, and IVDR approval, working in a regulated environment under design control. This role involves project timeline management, data interpretation, and mentorship of junior scientists. The position may also require handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.
Essential Duties & Responsibilities
Lead project studies supporting regulatory filings, working on multiple unrelated projects simultaneously
Train and mentor junior scientists, fostering a culture of scientific excellence
Execute and document product development work under design control and the company’s quality management systems, policies, and procedures
Develop and optimize study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory agency requirements
Perform complex statistical analyses independently or in coordination with statisticians
Interpret experimental results, draw conclusions, and define next steps to achieve project objectives
Ensure analyses and result interpretation are accurate and appropriate to support internal reports regulatory submissions, and scientific publications
Prepare clear, concise, and professional study reports to support regulatory submissions
Develop and deliver data-driven presentations for internal and external stakeholders
Create presentations to effectively communicate key research findings and project status
Lead technical discussions and project meetings, ensuring alignment with strategic goals
Ensure compliance with all safety and company policies, including biosafety and hazardous material handling protocols
Perform all other duties as assigned
Qualifications
Education & Experience:
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 in IVD product development
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
COVID-19 vaccination is recommended
Full-time on-site position. This is not a remote position.
Position may require occasional travel (<10%)
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 & vacation 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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