Universal Diagnostics S.A.
Bioinformatics Senior Manager
Universal Diagnostics S.A., Villa Espana Colonia, Texas, United States
Get AI-powered advice on this job and more exclusive features.
Universal D X, Inc. is an international company focused on cracking cancer’s code by developing multi-omics bioinformatics models that detect cancer in its earliest stages. Through our liquid‑biopsy platform, we are building a multi‑cancer assay that can identify the unique DNA regions associated with different types of cancers.
Opportunity We are seeking a Senior Bioinformatician to join our Bioinformatics team and contribute to the development, validation, and operational deployment of analytical pipelines supporting our liquid‑biopsy colorectal cancer (CRC) screening programs. This hands‑on role will focus on implementing robust, high‑quality bioinformatics solutions for NGS‑ and methylation‑based assays in the context of clinical studies and regulated product development.
Responsibilities
Develop, optimize, and maintain bioinformatics pipelines for cfDNA methylation analysis and NGS‑based assays (e.g., targeted methylation sequencing, WGBS, hybrid capture).
Implement high‑quality software and analysis code following best practices (version control, testing, documentation, reproducibility).
Contribute to statistical and machine‑learning workflows for biomarker extraction, classifier development, and performance analysis.
Generate documentation, validation reports, and analysis artifacts aligned with design control, quality systems, and regulatory requirements (e.g., IVDR, FDA submissions, CLIA/LDT workflows).
Execute analyses that support assay verification/validation, analytical performance studies, and clinical trial data deliveries.
Perform in‑depth analyses of NGS and methylation datasets, including feature extraction, QC, differential methylation analysis, classifier performance evaluation, and troubleshooting.
Support internal reports, presentations, and cross‑functional data reviews.
Interpret results relevant to CRC early detection and contribute to the scientific rationale.
Qualifications \>PhD, MSc, or equivalent in Bioinformatics, Computational Biology, Genomics, or related field. 3–5+ years of industry experience (biotech, medtech, diagnostics), ideally in cancer early detection, liquid biopsy, or NGS‑based diagnostics.
Strong expertise in NGS data processing for cfDNA or methylation‑based assays.
Expertise in methylation analysis, feature calling, biomarker discovery.
Statistical modeling and/or machine learning applied to diagnostic development.
Demonstrated ability to work in a regulated or product‑oriented environment, with familiarity in design controls, validation, documentation, and quality processes.
Proficiency in Python, workflow development (Nextflow, Snakemake, WDL), and cloud‑based computational environments.
Strong communication skills and ability to collaborate with multidisciplinary teams.
Ability to work in a fast‑paced, delivery‑focused environment with high operational rigor.
Preferred Qualifications
Experience supporting analytical validation, clinical studies, or regulatory submissions for molecular diagnostics (IVD, LDT, FDA, IVDR).
Familiarity with large‑scale data systems, cloud infrastructure (AWS/GCP/Azure), containerization (Docker), and CI/CD practices.
Understanding of wet‑lab processes and constraints in NGS assay development.
Prior experience translating research bioinformatics methods into reproducible, production‑ready pipelines.
Experience in CRC or other cancer early detection programs.
Benefits
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, vision insurance, life, STD, LTD coverage, and 401(k).
Flexible work schedule.
Relocation support to the DFW area for on‑site roles.
And more to come.
#J-18808-Ljbffr
Universal D X, Inc. is an international company focused on cracking cancer’s code by developing multi-omics bioinformatics models that detect cancer in its earliest stages. Through our liquid‑biopsy platform, we are building a multi‑cancer assay that can identify the unique DNA regions associated with different types of cancers.
Opportunity We are seeking a Senior Bioinformatician to join our Bioinformatics team and contribute to the development, validation, and operational deployment of analytical pipelines supporting our liquid‑biopsy colorectal cancer (CRC) screening programs. This hands‑on role will focus on implementing robust, high‑quality bioinformatics solutions for NGS‑ and methylation‑based assays in the context of clinical studies and regulated product development.
Responsibilities
Develop, optimize, and maintain bioinformatics pipelines for cfDNA methylation analysis and NGS‑based assays (e.g., targeted methylation sequencing, WGBS, hybrid capture).
Implement high‑quality software and analysis code following best practices (version control, testing, documentation, reproducibility).
Contribute to statistical and machine‑learning workflows for biomarker extraction, classifier development, and performance analysis.
Generate documentation, validation reports, and analysis artifacts aligned with design control, quality systems, and regulatory requirements (e.g., IVDR, FDA submissions, CLIA/LDT workflows).
Execute analyses that support assay verification/validation, analytical performance studies, and clinical trial data deliveries.
Perform in‑depth analyses of NGS and methylation datasets, including feature extraction, QC, differential methylation analysis, classifier performance evaluation, and troubleshooting.
Support internal reports, presentations, and cross‑functional data reviews.
Interpret results relevant to CRC early detection and contribute to the scientific rationale.
Qualifications \>PhD, MSc, or equivalent in Bioinformatics, Computational Biology, Genomics, or related field. 3–5+ years of industry experience (biotech, medtech, diagnostics), ideally in cancer early detection, liquid biopsy, or NGS‑based diagnostics.
Strong expertise in NGS data processing for cfDNA or methylation‑based assays.
Expertise in methylation analysis, feature calling, biomarker discovery.
Statistical modeling and/or machine learning applied to diagnostic development.
Demonstrated ability to work in a regulated or product‑oriented environment, with familiarity in design controls, validation, documentation, and quality processes.
Proficiency in Python, workflow development (Nextflow, Snakemake, WDL), and cloud‑based computational environments.
Strong communication skills and ability to collaborate with multidisciplinary teams.
Ability to work in a fast‑paced, delivery‑focused environment with high operational rigor.
Preferred Qualifications
Experience supporting analytical validation, clinical studies, or regulatory submissions for molecular diagnostics (IVD, LDT, FDA, IVDR).
Familiarity with large‑scale data systems, cloud infrastructure (AWS/GCP/Azure), containerization (Docker), and CI/CD practices.
Understanding of wet‑lab processes and constraints in NGS assay development.
Prior experience translating research bioinformatics methods into reproducible, production‑ready pipelines.
Experience in CRC or other cancer early detection programs.
Benefits
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, vision insurance, life, STD, LTD coverage, and 401(k).
Flexible work schedule.
Relocation support to the DFW area for on‑site roles.
And more to come.
#J-18808-Ljbffr