Senior Manager, R&D

2 hours, 34 minutes ago
Full-time
Lead
Project and Program Management
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004

Description

  • Lead technical development of NGS-based oncology assays, including project planning, execution, and cross-functional coordination.
  • Drive assay development from feasibility through verification and validation in a regulated CLIA environment.
  • Collaborate with Research, Informatics, Stats, Software, Regulatory, Quality, Commercial, and Operations teams to support development, launch, and commercialization.
  • Support post-launch assay activities, including troubleshooting, process improvements, and product lifecycle management.
  • Prepare and review technical documentation such as study protocols, reports, and validation documents for regulatory compliance.
  • Manage, mentor, and develop team members.
  • Perform and guide data analysis using statistical tools.
  • Help ensure robust and scalable product performance through partnership with Operations.

Requirements

  • PhD in Molecular Biology or a related field with 6+ years of industry experience, or BS/MS with 8+ years of relevant biotech industry experience.
  • At least 2 years of management experience.
  • Experience in NGS-based assay development in a regulated environment; CLIA experience preferred.
  • Familiarity with CLIA laboratory workflows and assay implementation in a production setting.
  • Demonstrated experience leading projects and collaborating cross-functionally.
  • Prior people management experience preferred.
  • Experience with high-throughput workflows or automation is a plus.
  • Technical expertise in oncology diagnostics and NGS technologies.
  • Strong technical writing, documentation, problem-solving, and analytical skills.
  • Understanding of regulatory requirements and design control processes, including LDT, CAP/CLIA, product development lifecycle, and change management.

Benefits

  • Annual performance incentive bonus.
  • Long-term equity awards.
  • Comprehensive health benefits, including medical, dental, and vision coverage.
  • 401(k) with company match.
  • Generous paid time off and company holidays.
  • Additional wellness and work-life benefits.
  • Life and disability plans for eligible employees and their dependents.
  • Pregnancy and baby bonding leave, fertility care benefits, commuter benefits, and employee referral program.

Interested in this position?

Apply directly on the company website

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