Senior Associate Scientist, IVD Test Dev

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; elevate complex issues appropriately.
• Prepare reagents, solutions, and study materials while ensuring traceability and proper documentation.
• Demonstrate accountability for assigned work streams, 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 experience preferable

Technical

Skills:

• Hands‑on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling. (Experience with automated immunochemistry analyzers…