R&D Scientist III, Immunoassay Development

Hands-on bench scientist leading end-to-end IVD immunoassay development from concept through verification/validation and transfer to production. Applies design control and risk management to ensure assay specifications align with user needs. Selects and optimizes critical components (antibodies, enzymes/conjugates, buffers), develops robust formulations, and conducts rigorous verification and validation studies per CLSI guidelines. Develops scalable manufacturing processes for bioconjugates, supports design transfer to production, and authors technical reports for regulatory filings. Requires independent project leadership, cross-functional collaboration, and strong problem-solving skills to advance products toward market launch.