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
We are seeking an experienced Manager, Manufacturing Operations to lead the build-out and operational excellence of our U.S.-based manufacturing facility in Dallas, TX. This individual will play a critical role in establishing scalable production systems for our cfDNA-based diagnostic assay platform, ensuring full compliance with FDA, ISO 13485, and CLIA requirements. The ideal candidate is a hands-on leader who thrives at the intersection of science, quality, and operations—driving consistent manufacturing performance and continuous improvement in a highly regulated environment.
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
- Design and implement laboratory layouts, clean/dirty workflows, and contamination controls.
- Oversee installation, qualification (IQ/OQ/PQ), and maintenance of core molecular biology and NGS instruments.
- Manage calibration, preventive maintenance, and environmental monitoring programs.
- Develop and maintain manufacturing SOPs, logs, and documentation for audit readiness.
- Recruit, train, and mentor laboratory staff to foster operational excellence and regulatory discipline.
- Oversee production scheduling, resource allocation, and performance tracking.
- Champion safety culture (biosafety, chemical, and general lab safety).
- Oversee procurement, inventory, and stock management of reagents, consumables, and packaging materials.
- Implement systems (manual or LIMS-based) for traceability, inventory control, and expiry monitoring.
- Manage supplier qualification and performance monitoring.
- Lead continuous improvement in logistics, packaging, and vendor relations.
- Identify, qualify, and manage suppliers and contract manufacturers.
- Negotiate supply agreements and service-level agreements (SLAs).
- Track vendor performance and develop risk mitigation strategies (e.g., dual sourcing).
- Supervise kit design, assembly, and QC for diagnostic and reagent products.
- Ensure packaging meets regulatory and quality standards for completeness and stability.
- Implement UDI/barcode traceability and FDA/ISO 13485–compliant labelling.
- Partner with QA/RA on global labelling and IFU requirements.
- Ensure all manufacturing and lab operations meet FDA, ISO 13485, GLP/GMP, and CLIA requirements.
- Collaborate with QA and Regulatory on audits, CAPAs, and continuous improvement.
- Maintain and update SOPs, work instructions, and manufacturing records.
- Support PMA submissions, validations, and manufacturing documentation readiness.
What You’ll Bring
- PhD in Molecular Biology, Chemistry, Bioengineering, or related field (or equivalent industry experience).
- Proven experience in NGS or diagnostic kit manufacturing, process validation, and regulatory documentation.
- Strong leadership background in lab or production environments.
- Deep familiarity with FDA/CLIA/ISO labelling, traceability, and QMS documentation.
- Experience managing suppliers, cold chain logistics, and inventory control systems.
- Excellent organizational, problem-solving, and people leadership skills.
- Experience with international kit distribution and multi-language labelling.
- Hands-on experience with UDI/barcode systems, LEAN packaging, or automated kitting.
- Proven success managing contract manufacturers or external production partners.
- Record of process improvement in regulated diagnostics or biotech environments.
- Strategic and operational mindset with a bias toward execution.
- Thrives in a fast-paced, matrixed, and mission-driven environment.
- Exceptional communication and collaboration skills.
- Willingness to travel (5–10%) to support manufacturing and supplier visits.
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.
What We´ll Offer
We’re proud to offer exceptional corporate benefits which include:
- 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 support to the DFW area for on-site roles.
- And more to come
