Director, Combination Product Development
Core
Lead and manage a multidisciplinary team of scientists and engineers to develop high-quality, safe, and effective device and combination products for injectable, respiratory, and transdermal therapies.
Role type
Senior people manager (Director) for combination product development
Builds
Advanced device technologies enabling drug delivery for respiratory, transdermal, biologic, biosimilar, and injectable therapies
Domain
Healthcare / Pharmaceutical device development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership and management, technical leadership for safety/efficacy/regulatory compliance, regulatory inspection readiness, design control strategy definition, manufacturing process development support, quality management system compliance
Preferred skills
Experience in pharmaceutical or combination product development, ability to convey complex technical information, problem-solving in fast-paced environments
Technologies
ISO 13485, FDA 21 CFR Part 820
Responsibilities
Lead and manage a multidisciplinary team of scientists and engineers, provide technical leadership for product safety and regulatory compliance, oversee critical development activities including design verification and stability studies, serve as key technical interface between drug and device teams, lead regulatory inspection readiness, ensure compliance with quality standards
Seniority
Director, people manager role
