Pipeline Verification & Validation Manager.

Pipeline Verification & Validation Manager. Avenel, NJ Job Details Contract 1 day ago Qualifications Project team coordination Bioinformatics FDA submissions Version control Next generation sequencing Azure Computer Science Test case design R Computational Biology Google Cloud Platform Master's degree Bash Team development Quality assurance audits AWS Doctor of Philosophy Team management Scientific protocols Quality control Algorithm design Mentoring CLIA regulations Developing data pipelines Scalability Regulatory submissions Master's degree in computer science Master's degree in bioinformatics Root cause analysis Senior level Cross-functional collaboration Bioinformatics data analysis Leadership Technical Proficiency Python Regulatory compliance management Cross-functional communication Engineering validation 10 years

Full Job Description 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.