Assay Lead
Core
Lead the development of new lateral flow immunoassays for hormones from concept to commercial release, ensuring performance specs and stability for a saliva-based home testing product.
Role type
Senior IC assay development lead (lateral flow immunoassays)
Builds
Commercially released lateral flow immunoassays for hormone monitoring
Domain
In vitro diagnostics (IVD), at-home testing, point-of-care diagnostics
Deliverable
production ML models | product features
Required skills
Lateral flow assay development, analytical validation, reagent formulation and stability, troubleshooting scale-up, research queue prioritization, technical communication to non-technical teams
Preferred skills
Saliva matrix experience, IVD/at-home testing background, hormone-specific assay experience, ISO 13485 or FDA regulatory experience, CRO or multi-startup experience
Technologies
Lateral flow immunoassays, analytical validation tools
Responsibilities
Lead development of new lateral flow immunoassays from concept to commercial release; Own performance specs and design/execute analytical validation studies; Manage reagent formulation, stability, and shelf life; Troubleshoot assay challenges during transfer and scale-up; Prioritize experiment queue and kill dead ends; Hire and grow the assay team; Communicate research progress to non-technical stakeholders; Maintain clear documentation of development and validation work
Seniority
Senior, hands-on IC