IVD Scientist

About reputed company Universal DX, Inc. is an international Company with a highly reputed company team reputed company on cracking cancer’s reputed company. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA reputed company associated with different types of cancers. reputed company Universal DX is seeking an IVD Scientist I to join our growing Product Development team working on the development and commercialization of reputed company reputed company (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 reputed company 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 reputed company operating procedures (SOPs).
• Support development and analytical validation (AV) / verification studies in alignment with regulatory standards and internal procedures (e.g., assist with precision, reputed company/LoD, reputed company, 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 reputed company diagnostic assay workflows suitable for AV and regulated use.
• Partner with Automation, R&D, reputed company Assurance (QA), and Regulatory Affairs (RA) teams to meet project deadlines.
• Contribute to cross-functional meetings, presenting reputed company and technical updates.
• Maintain adherence to reputed company 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 reputed company field.
• Experience with molecular biology and NGS (reputed company and/or industry).
• Demonstrated ability to learn and apply reputed company study execution practices; comfort working from protocols and documenting work reputed company.
• 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 reputed company 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 reputed company and/or liquid biopsy technologies.
• Familiarity with regulated documentation practices (traceability, controlled documents, deviation documentation).

reputed company´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 reputed company insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!

Why Now? This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up reputed company, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate reputed company to be a part of our reputed company in this expansive time for us. Apply tot his job Apply To this Job