Director, Reagent Development
Core
Lead a team to design, develop, and optimize NGS reagents (enzymes, buffers, chemistries) for clinical laboratory cancer diagnostics, ensuring GMP/ISO 13485 compliance from concept to manufacturing implementation.
Role type
Director, NGS Reagent Development (Senior IC with management)
Builds
Clinical-grade NGS reagents and kits for library preparation, target enrichment, and sequencing
Domain
Clinical diagnostics / Next-Generation Sequencing / Biochemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
NGS reagent development, enzymology, nucleic acid interactions, GMP/ISO 13485 compliance, Design of Experiments (DoE), statistical analysis, team leadership, assay validation, scale-up
Preferred skills
Raw material supply chain management, vendor interaction, cross-functional communication, strategic thinking
Technologies
NGS platforms, biochemical formulation tools, quality management systems (QMS)
Responsibilities
Direct and mentor R&D scientists; define project goals and manage timelines for reagent milestones; lead end-to-end development and optimization of NGS reagents; ensure strict adherence to GMP and ISO 13485 standards; partner with Product Development, Operations, and Bioinformatics teams for design transfer and production.
Seniority
Director, 10+ years industry experience, 5+ years in management
