Senior Associate Scientist, IVD Test Dev

Position: Senior Associate Scientist, IVD Test Dev Location: Cleveland, OH

Job Id: 217 # of Openings: 1

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 Senior Associate Scientist, IVD Test Development

Reports To This position will report to the 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; 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

Qualifications/Requirements

Bachelor's degree in biology, Biochemistry, Molecular Biology, or a related field with 2-4 years of relevant experience.

Master’s degree with 1-2 years of experience

Industry experience preferable

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

May require infrequent travel

Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)

Pay Range: $65,000 - $90,000 per year Apply for this Position