R&D Scientist III, Immunoassay Development
Core
Drive technical execution across the full In Vitro Diagnostics (IVD) product lifecycle, from concept and feasibility through verification, validation, and commercialization, focusing on immunoassay development.
Role type
Senior IC R&D Scientist (Immunoassay Development)
Builds
IVD immunoassay products for the clinical diagnostics market
Domain
Life Sciences / Clinical Diagnostics / In Vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunoassay development lifecycle management, Antigen-antibody interaction techniques, Antibody characterization and selection, Formulation development and optimization, Bioconjugation chemistry, Protein purification (chromatography), Upstream protein production, Root cause analysis, Experimental design, Regulatory compliance (FDA/ISO)
Preferred skills
Drugs of Abuse (DoA) and Therapeutic Drug Monitoring (TDM) experience, FDA 510(k) and EU IVDR pathway knowledge, Statistical software proficiency, Controlled substance handling
Technologies
Chromatography methods, Enzyme-labeling, Hapten-carrier protein coupling, Microsphere coating, Microsoft Office Suite
Responsibilities
Execute end-to-end assay development phases (Concept, Feasibility, Planning, Verification, Validation), Select and optimize critical assay components (antibodies, enzymes, buffers), Design and conduct verification/validation studies per CLSI guidelines, Develop and optimize manufacturing processes for bioconjugates, Establish preliminary manufacturing/QC processes for transfer to production, Translate technical requirements into actionable experimental plans, Perform root cause analysis on data anomalies, Author technical reports for regulatory filings
Seniority
Senior, hands-on IC
