Scientist II, Reagent QC for NGS Diagnostics

Universal Diagnostics; Fort Worth (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

PTO: 22 days

Company holidays + Birthday off

Comprehensive benefits: medical,Dental

Flexible work schedule

Job summary

Universal D X, Inc. seeks a Scientist II specializing in Reagent QC Development to advance QC methods for reagents used in NGS-based IVD assays. You will help ensure accuracy, reliability, and regulatory compliance across the product lifecycle.

You will collaborate with Manufacturing, QA, and Regulatory Affairs to transfer QC methods and maintain robust documentation, driving process optimization and compliance in a fast-paced environment.

Qualifications

• Master’s or Ph.D. in molecular biology, biochemistry, genetics or related field.
• 3+ years in product development for NGS-based IVD assays.
• Familiarity with FDA/IVDR and CLSI guidelines.

Responsibilities

• Develop and validate QC methods for reagents used in NGS-based IVD assays.
• Design stability studies to establish reagent shelf life and usage guidelines.
• Draft protocols, validation reports, and regulatory documentation.
• Collaborate with Manufacturing, QA, and Regulatory teams to ensure seamless QC integration.
• Identify opportunities to improve QC processes and ensure QMS compliance.

Skills

Analytical skills

Problem-solving

Project management

Regulatory knowledge

Education

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

Job description

Universal D X, Inc. seeks a Scientist II specializing in Reagent QC Development to advance QC methods for reagents used in NGS-based IVD assays. You will help ensure accuracy, reliability, and regulatory compliance across the product lifecycle.

You will collaborate with Manufacturing, QA, and Regulatory Affairs to transfer QC methods and maintain robust documentation, driving process optimization and compliance in a fast-paced environment.