Automation Development Scientist

The Opportunity:

Universal DX is seeking an experienced Automation Development Scientist to join our growing product development team working on the development and commercialization of Next Generation Sequencing (NGS) assays/products for early detection of colorectal cancer. Reporting to the Director of Automation Development, this role will support a team of US-based Automation Engineers and Assay Development Scientists as well as leverage global collaboration to fully automate Universal DX's colorectal cancer test for verification and validation testing. Additionally, this role will be a critical contributor to the technology transfer of Universal DX's colorectal cancer test to a strategic partner site (US-based) for regulatory approval and commercialization.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims 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:

• Key Contributor in the development of a blood-based early cancer detection test by fully automating manual NGS assay workflows. Collaborate with EU and US based Automation and assay development teams to develop automation solutions and workflows that meet the product requirements of Universal DX's colorectal cancer test.
• Interface with Assay Development, Bioinformatics, Quality, and other technical and functional groups to ensure the successful development and qualification of the NGS products.
• Collaboratively author and revise Verification and Validation protocols, SOPs and reports for new or existing products to ensure their successful implementation and transfer to the end-users.
• Lead troubleshooting efforts and analyze data to help drive key products related decisions.
• Work closely with Quality Assurance, Information Technology, and Regulatory groups to ensure the conformance of the automated product with Universal Diagnostics' regulatory requirements.

Qualifications:

• A hands-on Scientist with a minimum of 6 to 8 years of experience in molecular biology research and development, human genomic sequencing and related fields, with emphasis on NGS-based Assay Development and optimization of manual NGS protocols into automated workflows on Liquid Handling systems.
• Deep understanding of essential molecular biology methods such as PCR, qPCR, nucleic acids extraction and purification, quantitation, and quality control is required.
• Strong experience with statistical analysis methodologies, as well as data analysis software such as JMP.
• Experience in drafting SOPs/work instructions, Validation protocols and reports for automation systems, and experience with quality management, including design control, risk analysis and mitigation strategies.
• Experience in a regulated environment is a must and prior experience with clinical diagnostic products is highly desirable. Hands-on experience in the deployment of high throughput and fully automated NGS-based diagnostics in a Clinical laboratory setting is a strong plus.

What well offer:

We're proud to offer exceptional corporate benefits including:

• Flexible work schedule
• Accrued time off
• Company-sponsored benefit plans which include Paid Time Off, Medical, Dental, Vision, 401(k)
• Free day on your birthday
• Relocation support to the DFW area
• And more to come.