Manufacturing Engineer

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.

We are seeking a highly skilled Staff Manufacturing Specialist to lead manufacturing, functional QC, validation, and optimization within our IVD manufacturing operations. This role will drive technical excellence and compliance across complex workflows supporting our cfDNA-based multi-cancer detection platform. The ideal candidate combines strong engineering depth with GMP/ISO 13485 rigor and thrives in a fast-paced, mission-driven 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”.

• Own the Functional QC (FQC) strategy for the Signal-C Assay Manufacturing Program, ensuring assays are scientifically sound, phase-appropriate, and compliant with regulatory expectations.
• Collaborate closely with R&D to support the technology transfer of new assays, reagents, and controls into manufacturing FQC. Provide support on the design of fQC strategy that will be ultimately transferred into production.
• Optimize, qualify, and validate functional QC protocols for critical reagents, kits, controls, and panels included in Signal-C Assay Manufacturing Program.
• Define production acceptance criteria, control strategies, and trending approaches for FQC assays across reagent lifecycle.
• Act as the subject matter expert (SME) for functional performance testing of NGS-based diagnostic reagents, including cfDNA extraction, library prep, conversion, capture, amplification, and sequencing workflows.
• Support batch release activities by reviewing and approving FQC data, deviations, and investigations.
• Lead root cause analysis for FQC failures, assay drift, or OOS/OOT results, implementing CAPAs as needed.
• Work with Manufacturing Operations to ensure FQC assays are robust, scalable, and aligned with manufacturing throughput.
• Drive assay simplification, automation, and standardization efforts to improve reproducibility and operational efficiency.
• Implement statistical tools and data trending to monitor assay health and long-term performance.
• Work with Quality Assurance to ensure compliance with GMP, ISO 13485, CLIA, and FDA requirements, including support for audits and inspections.
• Interface with Supply Chain and external vendors to assess reagent changes, supplier qualifications, and material criticality from an FQC perspective.
• Author and review SOPs, protocols, validation reports, and technical justifications related to FQC assays.
• Contribute to regulatory submissions by providing functional QC methodologies, validation summaries, and scientific rationales.
• Ensure data integrity, traceability, and documentation completeness for all FQC activities.
• Serve as a technical leader and mentor for manufacturing personnel.
• Influence program strategy through IVD manufacturing expertise, technical rigor and risk-based decision making.
• Represent FQC in cross-functional program reviews and governance forums.

• PhD in Molecular Biology, Biochemistry, Biotechnology, Genetics, or a related scientific discipline (Master’s with significant industry experience may be considered).
• 8–12+ years of experience in IVD manufacturing, diagnostics, or biopharma, with a strong focus on QC and/or reagent development programs.
• Hands‑on experience with NGS workflows, including library preparation, indexing, capture, amplification, and sequencing.
• Demonstrated experience developing and validating…