Director, Site Lead Combination Product Development, R&D

Role: Senior leader overseeing combination product development at AbbVie's Lake County site, focusing on devices such as prefilled syringes, autoinjectors, on-body injectors, and infusion pumps. Objectives include driving innovation, ensuring technical rigor, and managing cross-functional teams for successful product lifecycle progression. Responsibilities encompass strategic and operational oversight of all development phases—from feasibility, design, verification, validation, to transfer—while building high-performing, multidisciplinary teams including engineering, science, and technical staff. The role involves collaborating with global R&D, Regulatory, Quality, and Manufacturing teams, managing resources and external partners, and championing continuous improvement and talent development. Qualifications include an MS/PhD in pharmaceutical or engineering disciplines, at least 15 years of industry experience with 8+ years leading product teams, ideally with expertise in electromechanical and subcutaneous injection devices, and knowledge of global regulatory standards (e.g., 21 CFR 820.30, ISO 13485). The candidate must demonstrate strong leadership, cross-functional communication, risk management, and a proven track record in device development leading to commercialization. Travel of 10-15% domestically and internationally is required. High-value specifics focus on combination product design for injectables, regulated under global standards, with responsibilities spanning early feasibility to product launch within a highly visible R&D setting.