Jobs at Personalis

Lead the global internal audit program and external audit readiness for a GxP-aligned clinical laboratory. Oversee audit lifecycle, regulatory inspections, executive reporting, CAPA investigations, and continuous improvement. Partner with cross-functional leaders, mentor audit staff, and ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, GCP, and GCLP.

The Histotechnician 2 processes FFPE specimens, performs staining and microtomy, generates digital slide images, ensures quality, and maintains documentation.

Personalis seeks great candidates to join their teams. Applicants are encouraged to apply even without a specific role posted. They offer a comprehensive compensation package and are committed to diversity and inclusion.

The Software Engineer II at Personalis will design, develop, and maintain Laboratory Information Management Systems, working on backend services, cloud deployment, and collaborating with cross-functional teams.

The role involves architecting, designing, and modernizing software systems for human genome sequencing, incorporating backend services and web applications, with a focus on automation and system integration.

The Bioinformatics Senior Scientist will develop and apply genomics products for cancer detection, leveraging machine learning and high-throughput genomic data analysis.

Lead design, development, testing, deployment, and maintenance of regulated clinical-lab software. Provide technical leadership, mentor engineers, improve CI/CD and integrations, ensure compliance (HIPAA, CLIA, CAP, FDA), support validation, and collaborate with stakeholders to deliver secure, reliable applications.

Lead software engineering and application support in a regulated clinical laboratory. Manage SDLC, Agile teams, offshore partners, production support, CI/CD/DevOps practices, integrations, monitoring, and compliance with HIPAA, CLIA, CAP, and FDA. Drive SLA/KPI management, incident reduction, audit readiness, and cross-functional collaboration.

Design, deploy, and operate secure, highly available cloud and hybrid infrastructure across AWS/Azure. Manage Kubernetes/Docker platforms, automate IaC and CI/CD pipelines, ensure monitoring, backup, and disaster recovery, and partner with security, compliance, and engineering teams to support PHI-sensitive, production-critical systems.

Lead computer system validation (GAMP 5) and software quality/compliance for clinical genomics software. Author/execute validation deliverables, enforce FDA/ISO/IEC regulatory alignment, run risk assessments (FMEA), integrate AI governance into QMS, support eQMS configuration, collaborate on cybersecurity and cross-functional design control documentation, and serve as SME during audits.

The Sr. Manager/Associate Director, Market Access will shape and execute the commercial payer strategy, engage stakeholders, and improve patient access to diagnostics through strategic collaboration and advocacy efforts.