IVD Scientist

The Opportunity:

Universal DX is seeking an IVD Scientist I to join our growing Product Development team working on the development and commercialization of Next Generation Sequencing (NGS) products for early cancer detection. This role will support the planning, execution, and documentation of analytical validation (AV) studies to characterize the performance of Universal DX's screening test for colorectal cancer.

This is an individual contributor scientist role intended for candidates early in their regulated IVD career. Candidates with substantially more IVD development experience than this role requires may be a better fit for our Senior IVD Scientist opening.

This role may be performed remotely (US) with regular cross-functional engagement, or on-site in the lab as needed.

How You'll Contribute:

* Draft and review technical documents, including protocols, reports, and standard operating procedures (SOPs).

* Support development and analytical validation (AV) / verification studies in alignment with regulatory standards and internal procedures (e.g., assist with precision, LoB/LoD, linearity, interference, robustness studies, as applicable).

* Execute study activities in the lab and/or coordinate study execution with internal partners and vendors; ensure accurate data capture and traceability.

* Coordinate the execution and analysis of studies with the lab and biostatistics teams.

* Identify and communicate technical challenges in assay workflow and assist with investigations and corrective actions under guidance.

* Collaborate with R&D teams to translate research findings into scalable diagnostic assay workflows suitable for AV and regulated use.

* Partner with Automation, R&D, Quality Assurance (QA), and Regulatory Affairs (RA) teams to meet project deadlines.

* Contribute to cross-functional meetings, presenting progress and technical updates.

* Maintain adherence to quality management systems (QMS) and ensure compliance with regulatory guidelines.

What you'll bring:

Required Qualifications

* Ph.D. in Molecular Biology, Biochemistry, Genetics, Bioengineering, or a related field.

* Experience with molecular biology and NGS (academic and/or industry).

* Demonstrated ability to learn and apply structured study execution practices; comfort working from protocols and documenting work clearly.

* Strong writing skills and experience with documentation (e.g., protocols, reports, lab records).

* Proficiency in the interpretation and documentation of study results.

* Proven ability to collaborate effectively with cross-functional teams.

* Excellent problem-solving, analytical, and organizational skills.

* Comfortable working in a fast-paced environment with ability to adapt to shifting priorities.

* Working knowledge of regulatory requirements and industry standards relevant to IVD development (e.g., FDA expectations and CLSI guideline concepts). (Support-level; not expected to have led a PMA.)

Preferred Qualifications

* Internship or industry experience supporting IVD analytical validation studies or design-control documentation.

* Experience with cfDNA methylation sequencing and/or liquid biopsy technologies.

* Familiarity with regulated documentation practices (traceability, controlled documents, deviation documentation).

What we´ll offer:

* 22 days of PTO with the possibility to carry over 10 days to the following year.

* Company Holidays, plus your Birthday off!

* Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).

* Flexible work schedule

* And more to come!