Senior Associate Scientist, IVD Test Dev

Cleveland Diagnostics•Cleveland, OH

8h•Onsite

About The Position

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. 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. 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.

Requirements

Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 2-4 years of relevant experience.
Master’s degree with 1-2 years of experience
Hands-on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling.
Ability to follow standard protocols and troubleshoot routine lab tasks
Experience with data analysis and documentation best practices
Proficient with computer skills and with Microsoft Office applications
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
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)

Nice To Haves

Industry experience preferable
(Experience with automated immunochemistry analyzers preferred).
Familiarity working in an FDA or ISO-regulated environment is a plus

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; 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

Benefits

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