Reagent QC Scientist II – NGS Diagnostics & Oncology

Universal Diagnostics; Fort Worth (TX); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

PTO 22 days with carryover

Company holidays + Birthday off

Insurance: medical, dental, vision + 4

401(k)

Flexible work schedule

Job summary

Universal DX, Inc. is expanding its US operations and seeks a Research Scientist II to lead reagent QC method development for NGS-based diagnostic assays. You will design validation plans, ensure reagent stability, and coordinate documentation for regulatory submissions.

The role involves cross-functional collaboration with Manufacturing, QA, and Regulatory Affairs, with a focus on fast-paced biotech advancement and cancer diagnostics impact.

Qualifications

• Requires advanced degree in a life sciences field and strong scientific foundation.
• Experience designing and executing QC-related studies in NGS/IVD contexts.
• Regulatory familiarity with FDA/IVDR and CLSI guidelines preferred.

Responsibilities

• Develop and validate reagent QC methods for NGS-based IVD assays.
• Establish reagent stability (freeze/thaw and onboard) and transfer QC methods to Manufacturing.
• Draft validation reports and ensure regulatory documentation accuracy.
• Collaborate across Manufacturing, QA, and Regulatory Affairs to enable seamless tech transfer.
• Identify process improvements to enhance QC efficiency and reproducibility.

Skills

Analytical skills

Project management

Regulatory knowledge

Problem-solving

Adaptability

Communication

Education

Master’s degree or Ph.D. in Molecular Biology, Biochemistry, Genetics, or related field

Job description

Universal DX, Inc. is expanding its US operations and seeks a Research Scientist II to lead reagent QC method development for NGS-based diagnostic assays. You will design validation plans, ensure reagent stability, and coordinate documentation for regulatory submissions.

The role involves cross-functional collaboration with Manufacturing, QA, and Regulatory Affairs, with a focus on fast-paced biotech advancement and cancer diagnostics impact.