Director Reagent Research and Development

Lead the scientific strategy and end-to-end execution of reagent research and development for a highly regulated immunohistochemistry (IHC) portfolio. This role guides a multidisciplinary R&D organization, ensures projects meet quality, regulatory, budget, and timeline expectations, and advances reliable reagent products from concept through transfer to manufacturing and commercialization.

Define and execute the reagent R&D strategy for the IHC portfolio, aligned with business priorities, product roadmaps, and regulatory requirements. Lead planning, prioritization, resourcing, and delivery across multiple concurrent reagent development programs. Ensure development work follows applicable IVD and IVDR design-control expectations, including risk management, verification and validation, traceability, and audit-ready documentation. Provide scientific direction for antibody development, detection chemistries, buffers, controls, ancillary reagents, analytical methods, and automated IHC technologies. Review and approve experimental plans, data packages, technical reports, design outputs, and project decisions. Apply Agile approaches, such as Scrum, Kanban, or hybrid methods, to improve visibility, iteration, cross-functional coordination, and predictable delivery. Partner with Quality, Regulatory, Operations, Product Management, Instrument R&D, manufacturing, customers, and other internal and external stakeholders. Guide transfer of reagent designs into manufacturing and support commercialization, audits, inspections, and post-development technical needs. Own departmental budgets, resource allocation, schedules, risk identification, and mitigation planning. Lead, coach, and develop an organization of approximately 25 to 30 employees, including four direct-report managers and the Histology Laboratory Manager. Oversee laboratory operations and reinforce good laboratory practices, safety, compliance, 5S, reproducibility, efficiency, and continuous improvement. Identify and implement technologies, automation, and process improvements that strengthen scientific rigor, throughput, and product quality. Communicate program status, risks, resource needs, and recommendations clearly to executive and cross-functional stakeholders. This is an onsite position Qualifications Bachelor’s degree in chemistry, biochemistry, biology, biomedical science, or a related scientific field. Scientific expertise sufficient to direct IHC reagent development, including antibody-based technologies, detection chemistry, cancer diagnostics, and laboratory automation. Demonstrated people leadership in a scientific or laboratory organization, including experience leading managers and developing technical teams. Ability to manage an IHC or related life-science laboratory using good laboratory practices; no laboratory certification is required for this role. Working knowledge of regulated product development and design controls in an IVD or similarly regulated environment. Ability to manage a portfolio of technical projects, balancing priorities, timelines, budgets, resources, risks, and documentation requirements. Practical experience applying Agile methods to scientific, product-development, or technical workflows. Strong stakeholder-management and communication skills, including the ability to work effectively with customers and senior leaders..

Master’s degree or doctorate in a relevant scientific discipline. Deep knowledge of IVDR requirements and audit or inspection readiness. Experience transferring reagent products from R&D into manufacturing and commercialization. Experience implementing 5S, laboratory automation, or other operational-excellence practices. Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least September 11, 2026 or until the job is no longer posted. The full-time equivalent pay range for this position is $210,528.00 -