Staff Scientist
Core
Lead the development, verification, and validation of IVD oncology assays and kits for the clinical market, supporting pharma-collaborative projects.
Role type
Staff Scientist (Study Lead & Technical SME)
Builds
IVD oncology assays and kits for clinical use
Domain
Genomics / Molecular Diagnostics / Precision Oncology
Deliverable
production ML models | product features
Required skills
IVD assay development, next-generation sequencing, experimental design, data analysis, protocol authorship, regulatory reporting (CLSI, ISO 13485), technical leadership, mentorship
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide technical leadership for the initiation, planning, development, troubleshooting, and validation of IVD oncology assays and kits; Lead team execution of formal IVD verification and validation protocols and regulatory reports; Manage and develop scientists through the design, execution, troubleshooting, analysis, and documentation of verification and validation studies; Author reports and present results, project updates, risks, mitigations, technology assessments, and technical roadmaps to colleagues, senior management, and leadership
Seniority
Staff, expanded technical leadership & mentorship