The Opportunity:

Universal DX is seeking an IVD Senior Scientist 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 Senior Scientist with direct experience supporting FDA PMA programs and contributing to FDA Pre-Sub/Q-Sub packages and responses, 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 cancer. 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, manage execution, and document analytical validation (AV) studies in alignment with regulatory standards and CLSI guidelines (e.g., precision, LoB/LoD, linearity, interference, robustness, as applicable).
• Define acceptance criteria with stakeholders; drive deviation investigations to closure with documented root cause and CAPA inputs as appropriate.
• Coordinate the execution and analysis of studies with the lab and bioinformatics teams, ensuring complete, traceable data packages.
• Identify and address technical challenges in assay workflow and help provide innovative solutions.
• Collaborate with R&D teams to translate research findings into scalable diagnostic assay workflows suitable for AV and regulated use.
• Partner with Lab Ops and Execution, Automation, Bioinformatics, Quality Assurance and regulatory consultants to meet project deadlines and ensure AV work products are submission-ready and support FDA interactions (Pre-Sub/Q-Sub) and PMA documentation 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:

• D. in Molecular Biology, Biochemistry, Genetics, or a related field.
• Analytical validation (AV) experience for an IVD, including planning/execution and documentation of AV 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.

 

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!