Senior Reagent QC Scientist – NGS Diagnostics

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

PTO 22 days

Birthday off

Insurance + life

Job summary

Universal DX, Inc. seeks a Research Scientist II to lead reagent QC method development for NGS-based IVD assays. You will design validation studies, establish reagent stability, and ensure regulatory compliance across CLSI standards.

You will collaborate with Manufacturing, QA, and Regulatory Affairs to transfer methods and documentation. Join us in advancing early cancer detection with robust QC processes.

Qualifications

• Master’s or PhD in Molecular Biology, Biochemistry, Genetics, or related field.
• 3+ years of experience developing reagent QC methods for NGS-based IVD assays.
• Familiarity with regulatory requirements (FDA, IVDR) and CLSI guidelines.
• Proven ability to design and manage validation studies.
• Excellent analytical, problem-solving and project management skills.

Responsibilities

• Reagent QC Method Development: develop/validate QC methods for reagents used in NGS-based IVD assays, ensuring accuracy and compliance.
• Reagent Stability Studies: establish in-use and long-term stability and onboard stability.
• Documentation And Reporting: draft validation protocols and reports for regulatory submissions and audits.
• Cross-Functional Collaboration: work with Manufacturing, Quality Assurance, and Regulatory Affairs.
• Process Optimization And Compliance: improve QC workflows and maintain QMS compliance.

Skills

Analytical skills

Problem-solving

Project management

Adaptability in fast-paced environment

Education

Master’s or PhD in Molecular Biology/ Biochemistry/ Genetics

Job description

Universal DX, Inc. seeks a Research Scientist II to lead reagent QC method development for NGS-based IVD assays. You will design validation studies, establish reagent stability, and ensure regulatory compliance across CLSI standards.

You will collaborate with Manufacturing, QA, and Regulatory Affairs to transfer methods and documentation. Join us in advancing early cancer detection with robust QC processes.