Position mission: to lead and oversee the development validation implementation and maintenance of bioinformatics pipelines and data analysis workflows for clinical molecular diagnostics ensuring compliance with UNE-EN ISO 15189 requirements and supporting the accurate timely and reliable reporting of patient results. The Bioinformatics Manager ensures that all computational aspects of diagnostic services meet quality standards support continuous improvement and contribute to clinical decision-making.
Tasks
- Design implement and maintain bioinformatics pipelines for variant detection annotation and reporting in compliance with UNE-EN ISO 15189.
- Collaborate with laboratory staff clinical scientists and IT to ensure data integrity secure storage traceability and confidentiality.
- Validate and document all software tools custom scripts databases and pipelines used in diagnostic workflows.
- Participate in risk assessments and ensure corrective/preventive actions (CAPAs) are documented and implemented for software or analysis issues.
- Lead continuous monitoring of pipeline performance including version control and change management.
- Develop and maintain SOPs related to bioinformatics processes and software use.
- Support accreditation audits and act as the primary point of contact for bioinformatics-related queries during assessments.
- Coordinate training of personnel involved in computational data analysis.
- Oversee integration of LIMS and ensure interoperability with bioinformatics workflows.
- Ensure timely data processing analysis and reporting aligned with turnaround time goals.
- Contribute to research and development of new assays and performance evaluation of new bioinformatics technologies.
Requirements
- MSc or PhD in Bioinformatics Computational Biology or related field.
- Minimum 35 years of experience in clinical bioinformatics or diagnostic laboratory setting.
- Strong knowledge of NGS data analysis (e.g. variant calling CNV fusion detection methylation).
- Familiarity with UNE-EN ISO 15189 and clinical validation of software tools.
- Experience with pipeline development (Snakemake Nextflow WDL etc.).
- Proficiency in scripting languages (Python R Bash).
- Knowledge of regulatory and quality frameworks: GDPR HIPAA UNE-EN ISO 15189 IVDR.
- Experience in software documentation validation protocols and traceability.
- Strong communication and leadership skills.
- Independence on a daily basis beyond the basic training is highly required.
Benefits
- Mission-Driven Impact Be part of a team fighting cancer through cutting-edge liquid biopsy and MRD technologies.
- Deep Tech Environment Collaborate with top scientists and engineers at the forefront of bioinformatics and NGS innovation.
- Flexible Work Setup Hybrid and remote options available with core hours adapted to scientific workflows.
- Continuous Learning Access to conferences courses and internal knowledge-sharing sessions.
- Collaborative Culture Work cross-functionally with clinical R&D and product teams in a fast-growing startup.