Director Reagent Research and Development
Core
Lead scientific strategy and end-to-end execution of reagent R&D for a highly regulated immunohistochemistry (IHC) portfolio, guiding projects from concept through manufacturing transfer and commercialization.
Role type
Director of Reagent Research and Development
Builds
Reliable IHC reagent products (antibodies, detection chemistries, buffers, controls) and automated IHC technologies
Domain
Life Sciences / In Vitro Diagnostics (IVD) / Immunohistochemistry
Deliverable
production ML models | product features
Required skills
IHC reagent development strategy, antibody-based technologies, detection chemistry, regulated product development (IVD/IVDR), laboratory operations, people leadership, project portfolio management, Agile methodologies, stakeholder management
Preferred skills
Master's or doctorate in relevant science, deep IVDR audit/inspection readiness knowledge, reagent transfer to manufacturing experience, laboratory automation implementation, 5S operational excellence
Technologies
Scrum, Kanban, automated IHC technologies
Responsibilities
Define and execute R&D strategy aligned with business priorities; lead planning and resourcing for multiple concurrent programs; ensure compliance with IVD/IVDR design controls; provide scientific direction for reagents and methods; review and approve experimental plans and technical reports; guide transfer to manufacturing; lead and develop a team of 25-30 employees; oversee laboratory operations and safety; implement automation and process improvements; communicate program status to executives.
Seniority
Director, strategic leadership with hands-on scientific direction