Senior Manufacturing Engineer

Universal Diagnostics; Fort Worth (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

22 days PTO

Birthday off

Medical, dental, vision insurance

401(k)

Flexible work schedule

Job summary

Universal DX, Inc, based in Texas, seeks a Senior Manufacturing Engineer to coordinate cGMP manufacturing and stability programs on site. You will oversee schedules, sample pulls, testing readiness, traceability, and cross-functional follow-up with the FQC Technical Lead and Quality.

Ideal candidates have 5+ years in GMP/manufacturing environments and hands-on molecular biology or NGS workflows. Join a fast-growing company building a multi-cancer diagnostic platform with ambitious societal

Qualifications

• Master’s or PhD in Life Sciences, Bioengineering, Chemical Engineering or related field.
• Typically 5+ years in GMP manufacturing, biopharma, reagent manufacturing, QC, analytical development, stability, or regulated labs.
• Hands-on experience with molecular biology and/or NGS-related workflows; QC testing experience is preferred.
• Experience coordinating stability studies, sample inventories, scheduled pulls, laboratory testing, or similar time-point driven programs.

Responsibilities

• Coordinate cGMP manufacturing and stability programs.
• Develop and maintain FQC and stability schedules, including sample-pull and testing timelines.
• Coordinate stability sample storage, inventory, pulls, testing, and documentation.
• Ensure stability activities follow approved protocols and defined time points.
• Maintain stability study records, trackers, sample inventories, and traceability.
• Monitor FQC and stability data for trends and execution risks.
• Coordinate technical review of unexpected results with QA and FQC Lead.
• Support preparation and completion of stability protocols and reports.
• Provide visibility into upcoming FQC/stability requirements and milestones.
• Support improvements of FQC and stability workflows and scheduling.
• Collaborate with Manufacturing, Quality, R&D and others to ensure readiness.

Skills

GMP Manufacturing

Stability Programs

Scheduling

Traceability

Technical Documentation

Cross-functional Coordination

Data Review

Problem Escalation

Education

Master's or PhD in Life Sciences, Bioengineering, Chemical Engineering or related

Tools

NGS workflows

Job 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:

We are seeking a Senior Manufacturing Engineer to coordinate cGMP manufacturing, stability program execution within Manufacturing Operations. This onsite role will provide technical and operational oversight for schedules, sample pulls, testing readiness, traceability, records, and cross-functional follow-up while partnering closely with the FQC Technical Lead and Quality. The ideal candidate is organized, technically strong, comfortable with regulated laboratory workflows, and able to translate approved protocols into reliable day-to-day execution.

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”.

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.

Primary Focus:

GMP Manufacturing and stability program coordination, technical oversight, scheduling, traceability, and execution readiness.

How you’ll contribute:

• Coordinate cGMP manufacturing and stability programs.
• Develop and maintain FQC and stability schedules, including sample-pull and testing timelines.
• Coordinate stability sample storage, inventory, pulls, testing, and associated documentation.
• Ensure stability activities are executed according to approved protocols and defined time points.
• Maintain stability study records, trackers, sample inventories, and traceability.
• Monitor FQC and stability data for trends, unexpected results, and operational concerns.
• Coordinate technical review and escalation of unexpected or out-of-trend results with the FQC Technical Lead and Quality.
• Support preparation, execution, and completion of stability protocols and reports.
• Provide visibility into upcoming FQC/stability requirements, resource needs, risks, dependencies, and study milestones.
• Support continuous improvement of FQC and stability workflows, scheduling, and operational execution.
• Partner with Manufacturing, Quality, R&D, and other stakeholders to ensure samples, methods, equipment, materials, and documentation are ready before scheduled activities.
• Support investigations, deviations, CAPA actions, audit/inspection requests, and data/record retrieval associated with assigned FQC and stability activities.

What you’ll bring:

• Master’s degree or PhD in Life Sciences, Bioengineering, Chemical Engineering or a related technical discipline.
• Typically 5+ years of experience in GMP manufacturing, biopharma, reagent manufacturing, QC, analytical development, stability, or a regulated laboratory environment.
• Hands‑on experience with molecular biology and/or NGS‑related laboratory workflows; experience supporting functional or performance‑based QC testing is strongly preferred.
• Experience coordinating stability studies, sample inventories, scheduled pulls, laboratory testing, or similar time‑point driven programs.
• Strong scheduling, traceability, technical documentation, data review, and cross‑functional coordination skills.
• Ability to recognize trends, unexpected results, and execution risks and elevate them through the appropriate technical and Quality channels.
• Comfort working onsite in a hands‑on manufacturing/laboratory environment and supporting multiple concurrent studies and manufacturing priorities.

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.
• 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.