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technical writing data analysis cross-functional collaboration leadership ngs📋 Description
- Lead development of NGS oncology assays and cross-functional coordination
- Drive feasibility through verification/validation in a CLIA-regulated setting
- Collaborate with R&D, Informatics, Stats, Software, Regulatory, Quality, and Commercial teams
- Support post-launch optimization and operations for commercialized assays
- Prepare and review study protocols, reports, and validation documentation
- Manage and mentor team members
- Perform and guide data analysis using statistical tools
🎯 Requirements
- PhD in Molecular Biology or related with 6+ years, or BS/MS with 8+ years biotech, incl. 2+ yrs mgmt
- NGS-based assay development in regulated CLIA environment
- Familiarity with CLIA workflows and production assay implementation
- Demonstrated project leadership and cross-functional collaboration; prior people mgmt preferred
- High-throughput workflows or automation experience a plus
- Technical expertise in oncology diagnostics and NGS
- Technical writing and documentation in regulated environments
- Regulatory requirements and design control (LDT, CAP/CLIA)
🎁 Benefits
- Annual performance incentive bonus
- Long-term equity awards
- Comprehensive health benefits (medical, dental, vision)
- 401(k) with company match
- Generous paid time off and company holidays
- Fertility care benefits
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