Job Description: We are seeking an experienced Bioinformatics Pipeline Validation Manager to lead a high-impact team responsible for validating, optimizing, and maintaining robust bioinformatics workflows. This role is critical to our client's mission, ensuring that analytical pipelines meet stringent scientific, quality, and regulatory standards. The ideal candidate brings a strong foundation in bioinformatics, hands-on experience with NGS pipelines, and proven leadership or team-management capability.
Responsibilities :
- Leadership & Team Management
- Lead, mentor, and develop a team of bioinformatics validation scientists and analysts.
- Oversee workload planning, project assignment, and team performance tracking.
- Foster a collaborative, high-performance team culture focused on quality and innovation.
- Pipeline Validation & Quality Assurance
- Own end-to-end validation of bioinformatics pipelines (NGS, WGS/WES, RNA-seq, variant calling, annotation, QC workflows, etc.).
- Develop validation plans, protocols, test cases, and acceptance criteria.
- Ensure pipelines meet regulatory requirements (CLIA, CAP, FDA, or equivalent, where applicable).
- Execute software verification & validation (SV&V), documenting all results thoroughly.
- Requirements:
- Master's or Ph.D. in Bioinformatics, Computational Biology, Genomics, Computer Science, or related field.
- 6-10+ years of industry experience in bioinformatics, including pipeline development or validation.
- Strong understanding of NGS technologies and analytical methods (alignment, variant calling, QC metrics, annotation tools, etc.).
- Experience validating bioinformatics tools in regulated or semi-regulated environments.
- Proficiency with workflow systems (e.g., Nextflow, Snakemake, WDL/Cromwell) and programming languages such as Python, R, or Bash.
- Familiarity with cloud-based computational environments (AWS, Azure, GCP) is a strong plus.
- Demonstrated people management or technical leadership experience.
- Must have:
- Clinical Cancer NSG Bioinformatics pipeline'. Candidate must have worked in Cancer genomics area.
- Bioinformatics NGS Cancer Genomics Analysts
- Strong Genomics NGS Data Analyst with algorithm development background who has the ability to support validation of bioinformatics pipelines for products being submitted to CAP, CLIA, FDA, New York Department ofhealth and MolDx
Technical Expertise & Execution: - Collaborate closely with bioinformatics engineers, data scientists, and software developers to refine pipeline design and performance.
- Evaluate new tools, algorithms, and software for integration into analytical workflows.
- Troubleshoot pipeline failures and drive root-cause analyses.
- Ensure reproducibility, scalability, and robustness of computational workflows.
- Cross-Functional Collaboration
- Work with wet-lab teams, quality assurance, clinical operations, and product management to align validation objectives with project deadlines and business needs.
- Represent the validation team in client meetings, audits, and technical reviews.
- Documentation & Compliance
- Maintain detailed records of validation activities, version control, and release notes.
- Prepare documentation for regulatory submissions and internal quality audits.
- Establish and enforce validation standards, SOPs, and best practices.
