Director, Site Lead Combination Product Development, R&D
Core
Lead the Lake County Combination Product Development (CPD) team to drive clinical development of combination products including prefilled syringes, autoinjectors, on-body injectors, and subcutaneous ambulatory infusion pumps.
Role type
Director, Site Lead for Combination Product Development
Builds
New device and platform technologies for drug delivery systems
Domain
Pharmaceutical industry, medical devices, drug delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
strategic and operational leadership, feasibility assessment, design analysis and optimization, reliability engineering, specifications development, verification testing, issue resolution, resource allocation, global regulatory knowledge, cross-functional collaboration, team building, talent development, third-party partner management
Preferred skills
experience with subcutaneous injection devices, electromechanical devices, commercial launch leadership, lean product development methodologies
Technologies
21 CFR 820.30, ISO 13485, MDR
Responsibilities
Provide strategic and operational leadership for all combination product development activities at the LC site, Direct oversight spans early feasibility assessment, design analysis and optimization, platform customization, reliability engineering, specifications development, verification testing, and issue resolution across the full program lifecycle, Oversee project teams responsible for the broader product development lifecycle—from concept through design, engineering, verification/validation, and transition to operations, Build and lead a high-performing, multidisciplinary site team comprising engineering, science, and technical staff, Lead engineers responsible for design fundamentals, margin analysis, reliability assessment, and continuous improvement opportunities across a diverse portfolio of delivery systems, Oversee the lab and design verification teams to support design, development, and testing of combination products using state-of-the-art equipment, Proactively manage global third-party development partners across a broad range of drug delivery system technologies and device types
Seniority
Director, strategic and operational leadership