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 be instrumental in the planning, design, execution, and documentation of analytical validation (AV) studies to characterize the performance of Universal DX's screening test for colorectal cancer.

This position is intended for an IVD scientist with direct experience supporting FDA PMA programs and FDA Pre-Sub/Q-Sub interactions, and who can plan, manage and execute AV studies in accordance with CLSI guidelines. The role may be performed remotely (US) with regular cross-functional engagement, or on-site in the lab as needed.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

How you'll contribute:

* Draft, review, and maintain high-quality technical documents including analytical validation (AV) protocols, validation reports, and standard operating procedures (SOPs).

* Plan and document development and AV / V&V studies in alignment with regulatory standards and CLSI guidelines (e.g., precision, LoB/LoD, linearity, interference, robustness, as applicable).

* Coordinate the execution and analysis of studies with the lab and biostatistics teams, ensuring complete, traceable data packages.

* Identify and address technical challenges in assay workflow and help provide innovative solutions, including investigation and documentation of deviations as needed.

* 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, and Regulatory Affairs teams to meet project deadlines and ensure AV work products support FDA interactions (Pre-Sub/Q-Sub) and PMA submission needs.

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

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

What you'll bring:

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

* Analytical validation (AV) experience for an IVD, including planning/execution and documentation of AV/V&V studies in accordance with CLSI guidelines.

* Experience contributing to FDA PMA submissions for an IVD, including FDA Pre-Sub/Q-Sub submissions and interactions.

* Experience with molecular biology and NGS; ability to interpret NGS assay performance metrics and troubleshoot workflow issues.

* Proficiency in the interpretation, analysis, and documentation of study results; strong technical writing skills.

* Proven ability to collaborate effectively with cross-functional teams, manage priorities, and deliver under timelines in a fast-paced environment.

Preferred Qualifications:

* Experience with cfDNA methylation sequencing and liquid biopsy technologies.

* Hands-on experience with verification and validation (V&V) of IVD products in a design-controlled/QMS environment.