Scientist II, Reagent QC Development

Universal Diagnostics; Fort Worth (TX); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

PTO: 22 days

Company holidays + Birthday off

Comprehensive benefits: medical,Dental

Flexible work schedule

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical skills

Problem-solving

Project management

Regulatory knowledge

Formation

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

Description du poste

About our Company:

Universal D X, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. 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 regions associated with different types of cancers.

The Opportunity:

We are seeking a highly motivated Scientist II specializing in Reagent QC Development to join our rapidly growing team. This role will play a critical role in developing and executing quality control (QC) methods for reagents used in our NGS-based diagnostic assays. Reporting to the Director, Reagent Development, this role will oversee reagent QC method development as well as establish reagent stability to ensure robust assay performance and compliance with regulatory standards. This role will also play an integral role in coordinating the transfer of reagent QC methods and related documentation to the Reagent Manufacturing team.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. 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:

Reagent QC Method Development:

• Support the development and validation of QC methods for assay-critical reagents used in next-generation sequencing (NGS)-based in vitro diagnostic (IVD) assays, ensuring accuracy, reliability, and compliance with CLSI guidelines and regulatory standards.
• Design and implement studies to support a comprehensive validation framework for reagent QC methods for NGS workflows.
• Optimize and scale QC workflows to enhance efficiency, reproducibility, and robustness, integrating risk-based approaches to reagent quality control.

Reagent Stability Studies:

• Design and execute studies to establish the in use and long-term stability of reagents, ensuring long-term reliability.
• Partner with Data science team to analyze stability data and determine reagent shelf life and usage guidelines.

Documentation and Reporting:

• Draft and review study protocols, validation reports, and other technical documentation.
• Ensure thorough and accurate record-keeping to support regulatory submissions and audits.

Cross-Functional Collaboration:

• Partner with internal teams, including Manufacturing, Quality Assurance, and Regulatory Affairs, to ensure seamless integration of reagent QC strategies across the product lifecycle.
• Collaborate with internal and external partners to facilitate process transfer and QC testing.

Process Optimization and Compliance:

• Identify opportunities for process improvement and implement solutions to enhance efficiency and reproducibility.
• Maintain adherence to quality management systems (QMS) and regulatory compliance throughout all QC activities.

What you'll bring:

Required:

• Master’s degree or Ph.D. in Molecular Biology, Biochemistry, Genetics, or a related field.
• 3+ years of experience in product development (assay and/or reagent and/or QC methods development) for NGS-based IVD assays.
• Familiarity with regulatory requirements (e.g., FDA, IVDR) and industry standards (e.g., CLSI guidelines).
• Proven ability to design and manage validation studies.
• Excellent analytical, problem-solving, and project management skills.
• Comfortable working in fast-paced environment with ability to adapt to shifting priorities.

Preferred:

• Understanding of reagent QC method development, including functional and stability testing.
• Experience in oncology diagnostics or liquid biopsy assays.
• Familiarity with automation systems and high-throughput platforms.
• Prior experience transferring reagent QC methods from R&D to Manufacturing teams.

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!

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.