Director, Site Lead Combination Product Development, R&D
AbbVie
August 23, 2026
On-site
North Chicago, IL
$182,000 - $346,000 USD yearly
Clinical Research and Development
Responsibilities:
- Provide strategic and operational leadership for all combination product development activities at the Lake County (LC) site, driving device and drug-device platform innovation.
- Oversee early feasibility, design analysis/optimization, platform customization, reliability engineering, specifications development, verification testing, and issue resolution across the program lifecycle.
- Lead project teams through concept, design, engineering, verification/validation, and transition to operations.
- Build and lead a multidisciplinary site team (engineering, science, technical staff), directly managing managers, project leads, and technical specialists.
- Lead lab and design verification teams; oversee development/testing using state-of-the-art equipment.
- Collaborate with R&D, Regulatory, Quality, Operations, and Supply to meet timelines and regulatory requirements; provide technical leadership and granular insights.
- Develop and manage resource allocation, tools/equipment, laboratory capabilities, and talent; implement staffing plans using internal and external resources.
- Foster technical rigor, quality, and continuous improvement; proactively resolve technical/operational issues.
- Manage third-party development partners; represent LC in cross-site collaborations and leadership forums.
Qualifications:
- MS/PhD in pharmaceutical or engineering discipline.
- 15+ years relevant industry experience; 8+ years leading product development teams (subcutaneous injection devices and electromechanical devices highly desirable).
- Expertise in combination product/device design, development, verification/validation, and technology transfer (commercial launch a plus).
- Knowledge of global regulatory requirements/standards (e.g., 21 CFR 820.30, ISO 13485, MDR).
- Lean product development experience across large multidisciplinary teams.
- Cross-functional process improvement; ability to navigate risk/ambiguity.
- Strong leadership, communication, and stakeholder influence; strategic planning and resource allocation expertise.
- Travel required (10%-15%).
- Provide strategic and operational leadership for all combination product development activities at the Lake County (LC) site, driving device and drug-device platform innovation.
- Oversee early feasibility, design analysis/optimization, platform customization, reliability engineering, specifications development, verification testing, and issue resolution across the program lifecycle.
- Lead project teams through concept, design, engineering, verification/validation, and transition to operations.
- Build and lead a multidisciplinary site team (engineering, science, technical staff), directly managing managers, project leads, and technical specialists.
- Lead lab and design verification teams; oversee development/testing using state-of-the-art equipment.
- Collaborate with R&D, Regulatory, Quality, Operations, and Supply to meet timelines and regulatory requirements; provide technical leadership and granular insights.
- Develop and manage resource allocation, tools/equipment, laboratory capabilities, and talent; implement staffing plans using internal and external resources.
- Foster technical rigor, quality, and continuous improvement; proactively resolve technical/operational issues.
- Manage third-party development partners; represent LC in cross-site collaborations and leadership forums.
Qualifications:
- MS/PhD in pharmaceutical or engineering discipline.
- 15+ years relevant industry experience; 8+ years leading product development teams (subcutaneous injection devices and electromechanical devices highly desirable).
- Expertise in combination product/device design, development, verification/validation, and technology transfer (commercial launch a plus).
- Knowledge of global regulatory requirements/standards (e.g., 21 CFR 820.30, ISO 13485, MDR).
- Lean product development experience across large multidisciplinary teams.
- Cross-functional process improvement; ability to navigate risk/ambiguity.
- Strong leadership, communication, and stakeholder influence; strategic planning and resource allocation expertise.
- Travel required (10%-15%).