Director Reagent Research and Development

Role: Lead the scientific strategy and execution of reagent R&D for a regulated immunohistochemistry (IHC) portfolio, overseeing projects from concept to manufacturing transfer and commercialization. Responsibilities: define R&D strategies aligned with regulatory standards (IVDR), lead multidisciplinary teams (~25-30 staff), manage budgets and resources, ensure compliance with design controls, facilitate transfer of reagent products, and implement process improvements. Actively collaborate with Quality, Regulatory, Operations, and stakeholders, providing technical leadership in antibody development, detection chemistries, and automation, while overseeing laboratory operations and compliance. Qualifications: Bachelor's degree in a relevant scientific field; extensive expertise in IHC reagent development, including antibody and detection chemistry; proven leadership in a scientific or lab setting; experience managing regulated product development in an IVD environment; familiarity with Agile methodologies, design controls, and project management. Preferred: Master’s or PhD, deep IVDR knowledge, experience in manufacturing transfer, and operational excellence practices. High-Value specifics: focus on cancer diagnostics, biologics, regulated in vitro diagnostic products, clinical-stage development, and cross-functional stakeholder engagement. Work setup: Onsite, with 10% travel. The role emphasizes leadership in scientifically advanced, regulated biotech environments, ensuring project delivery, compliance, and continuous improvement.