Description
About our Company:
Universal DX, 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:
Universal DX is seeking an experienced Principal NGS Automation Architect to lead the design, development, implementation, and continuous improvement of automated next-generation sequencing (NGS) laboratory workflows supporting in vitro diagnostic (IVD) assay development, analytical validation, and commercialization. Reporting to the VP of Product Development, this role serves as the technical bridge between assay development, laboratory operations, automation engineering, software, quality assurance, and regulatory affairs teams to ensure that automated solutions meet analytical, operational, and regulatory requirements. The successful candidate will possess deep, hands-on liquid-handling method development and systems-level architecture expertise for NGS workflows, a strong understanding of molecular assay requirements, and experience developing robust, scalable, and compliant automation suitable for clinical and IVD environments.
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:
Automation Architecture and Development
- Design the end-to-end automation architecture for NGS sample preparation and in-process quality control workflows.
- Evaluate, select, and implement laboratory automation platforms, integrated devices, labware, consumables, and supporting technologies.
- Develop automation strategies that maximize throughput, reproducibility, robustness, and operational efficiency.
- Develop and optimize liquid handling methods including deck layouts, labware definitions, liquid classes and pipetting parameters, mixing, temperature control, and error-recovery strategies, to maintain assay performance while minimizing carryover, variability, and failure modes.
Assay Integration
- Serve as the primary technical interface between assay development scientists and automation engineers.Translate assay requirements design inputs, critical process parameters, and control strategies into automated workflows while maintaining analytical performance.
Quality, Regulatory, and Compliance
- Design automation solutions in accordance with applicable quality systems and regulatory requirements for IVD products.
- Generate and review documentation.
Continuous Improvement and Cross Functional Collaboration
What you’ll bring:
- Bachelor's, Master's, or Ph.D. in Molecular Biology, Biomedical Engineering, Bioengineering, Biotechnology, Chemical Engineering, Automation Engineering, or a related scientific or engineering discipline.
- 8+ years of experience developing and deploying automated laboratory workflows for molecular diagnostics, genomics, or biotechnology. Experience supporting automation of DNA methylation assays and liquid biopsy workflows is preferred.
- Demonstrated experience automating NGS workflows including library preparation and target enrichment.
- Hands-on experience with liquid handling robotics and laboratory automation systems (e.g., Hamilton, Tecan, Beckman Coulter, or similar).
- Experience translating assay development requirements into automated laboratory processes.
- Knowledge of NGS technologies and molecular biology techniques.
- Experience working within regulated IVD, CLIA, CAP, or FDA-regulated environments.
- Experience with Design Controls, risk management, verification, validation, and lifecycle documentation.
- Experience authoring technical documentation supporting regulated product development.
- Strong analytical and troubleshooting skills.
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.
- Relocation bonus when applicable.
Why Now?<
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