Senior Associate Scientist, IVD Test Dev

Cleveland Diagnostics Inc.

Cleveland (OH)

On-site

USD 65,000 - 90,000

Full time

40 hours ago

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Benefits offered by this job

100% Employer‑paid medical for single,

100% Employer‑paid Dental & Vision for

4% retirement contribution Employer

Promotion/Performance Pay, Incentive &

Paid Family Leave Program and more

Job summary

Cleveland Diagnostics seeks a Senior Associate Scientist for IVD Test Development to drive assay development, verification and validation in a regulated setting. You will execute experiments, analyze data, and contribute to regulatory submissions while ensuring quality documentation and adherence to design control.

The role involves hands-on laboratory work with human-derived specimens, collaboration across teams, and continuous improvement initiatives to support internal clinical lab use and

Qualifications

Bachelor’s degree in biology, biochemistry, molecular biology, or related field with 2–4 years of experience.
Master’s degree with 1–2 years of experience.
Industry experience is preferred.

Responsibilities

Design and plan laboratory experiments with clearly defined objectives and success criteria.
Independently execute experiments supporting assay development and validation per protocols and design control requirements.
Prepare data summaries, figures, tables, and interpretations for internal technical review.
Maintain accurate, GDP/QMS-compliant documentation and records.
Coordinate with vendors and teams to procure lab supplies and ensure readiness.

Skills

Laboratory techniques

Data analysis

Troubleshooting

Regulatory compliance

Statistical analysis

Documentation

Education

Bachelor’s degree in biology/biochemistry/molecular biology

Master’s degree with 1–2 years of experience

Tools

Immunochemistry analyzers

Excel

QMS documentation systems

Job description

We are seeking a Senior Associate Scientist-IVD Test Development to 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.

Job Title SeniorAssociate Scientist, IVD Test Development

Reports To This positionwill report tothe Sr Director, IVD Test Development

Job Overview The Senior Associate Scientist will support in‑vitro diagnostic assay development and validation activities within a regulated environment. This role will execute laboratory experiments and contribute to assay optimization, verification, and validation studies supporting regulated diagnostic products requiring PMA, 510(k), and IVDR submissions, as well as laboratory‑developed tests (LDTs) which are validated for internal clinical laboratory use. The position 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. The Senior Associate Scientist will perform routine and non‑routine laboratory procedures, analyze and summarize data, maintain accurate documentation in accordance with quality system requirements, and assist in preparing technical reports and study documentation. In addition to laboratory execution, this position will support lab organization, equipment maintenance, reagent preparation, and continuous improvement initiatives to ensure efficient study execution. The role involves 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

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; elevate 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

Qualifications/Requirements

Bachelor's degree in biology, Biochemistry, Molecular Biology, or a related field with2-4 years of relevant experience.
Master’s degree with1-2years of experience
Industry experiencepreferable

Technical Skills:

Hands‑on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling. (Experience with automated immunochemistry analyzers preferred).
Ability to follow standard protocols and troubleshoot routine lab tasks
Experience with data analysis and documentation best practices
Familiarity working in an FDA or ISO‑regulated environment is a plus
Proficient with computer skills and with Microsoft Office applications
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
Requires Hepatitis B vaccination or appropriate waiver (working with blood‑based samples)

Pay Range: $65,000 - $90,000 per year

Cleveland Diagnostics develops next‑generation diagnostic tests to detect cancer earlier and more accurately. We combine clinical science, engineering, and commercial rigor to move breakthrough diagnostics from concept to patient impact.

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 Basic Group Term Life, Short- & Long‑Term Disability
4% retirement contribution Employer match
Promotion/Performance Pay, Incentive Performance Plan & Stock Option Program & Commissions (Sales Account Execs)
Paid Family Leave Program and the rest of the alphabet soup: EAP, FSAs, HSA & more!
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Salary range may vary by work state, depth of education & experience, geographical region/territory
Onsite Employees:
Easy to get to office location with newly built‑out office space & FREE parking!
Free coffee, snacks, a cool new Bevi sparkling water machine 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.

All employment decisions without regard to race, creed, religion, color, national origin, and ancestry, known or perceived mental or physical disability, age, marital or familial status, pregnancy or related medical conditions, sex/gender (including pregnancy/childbirth, sexual orientation and gender identity or expression), transgender status, domestic violence or sexual assault victim status genetic information, military or veteran status, or any other status protected under applicable federal, state, or local laws.

This policy applies to all terms and conditions of employment, including but not limited to: recruiting, hiring, placement, promotion, assignment of duties, termination, layoff, recall, transfer, leaves of absence, benefits, compensation and training.

The Company seeks to comply with all applicable federal, state and local laws where we operate.

We hire differently abled people!

Cleveland Diagnostics (CDx) will provide reasonable accommodations for qualified individuals with disabilities, applicants who qualify under the Americans with Disabilities Act, as Amended, may be eligible for a reasonable accommodation in CDx’s application and selection processes.

A request for an accommodation will not affect your opportunities for employment with CDx. Arrangements can be made if you have a disability that requires an accommodation for completing an application, interviewing or any other part of the employment process.

If you require an accommodation in making an application through our online system, please either call 833-265-7337 or send an email to: CDx.HR@ClevelandDx.com. (This phone line and email address are not to be used for checking on the status of an already submitted application.) You will need to provide your name, a phone number, email address or other means of contacting you, and a brief description of the nature of the requested accommodation. CDx will be in contact with you to discuss your request.

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