Director Reagent Research and Development
Quick Summary
Job Description Lead the scientific strategy and end-to-end execution of reagent research and development for a highly regulated immunohistochemistry (IHC) portfolio.
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.
Responsibilities
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Define and execute the reagent R&D strategy for the IHC portfolio, aligned with business priorities, product roadmaps, and regulatory requirements.
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Lead planning, prioritization, resourcing, and delivery across multiple concurrent reagent development programs.
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Ensure development work follows applicable IVD and IVDR design-control expectations, including risk management, verification and validation, traceability, and audit-ready documentation.
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Provide scientific direction for antibody development, detection chemistries, buffers, controls, ancillary reagents, analytical methods, and automated IHC technologies.
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Review and approve experimental plans, data packages, technical reports, design outputs, and project decisions.
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Apply Agile approaches, such as Scrum, Kanban, or hybrid methods, to improve visibility, iteration, cross-functional coordination, and predictable delivery.
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Partner with Quality, Regulatory, Operations, Product Management, Instrument R&D, manufacturing, customers, and other internal and external stakeholders.
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Guide transfer of reagent designs into manufacturing and support commercialization, audits, inspections, and post-development technical needs.
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Own departmental budgets, resource allocation, schedules, risk identification, and mitigation planning.
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Lead, coach, and develop an organization of approximately 25 to 30 employees, including four direct-report managers and the Histology Laboratory Manager.
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Oversee laboratory operations and reinforce good laboratory practices, safety, compliance, 5S, reproducibility, efficiency, and continuous improvement.
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Identify and implement technologies, automation, and process improvements that strengthen scientific rigor, throughput, and product quality.
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Communicate program status, risks, resource needs, and recommendations clearly to executive and cross-functional stakeholders.
Requirements
~1 min readBachelor’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.
Location & Eligibility
Listing Details
- Posted
- September 4, 2026
- First seen
- September 7, 2026
- Last seen
- October 6, 2026
Posting Health
- Days active
- 29
- Repost count
- 0
- Trust Level
- 32%
- Scored at
- October 6, 2026
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