Combination Product Development

Description

• Lead and manage a multidisciplinary team of scientists and engineers supporting device development for injectable, respiratory, and transdermal combination products.
• Build, develop, and retain a high-performing team aligned to evolving portfolio and technology needs.
• Provide technical leadership to ensure generation of robust evidence demonstrating product safety, efficacy, reliability, and regulatory compliance.
• Serve as the key technical interface between drug product and device teams across combination product development.
• Oversee critical development activities, including design verification, stability, biological evaluation, extractables, and transport studies.
• Ensure development and implementation of device control strategies to support manufacturing and successful technology transfer.
• Support manufacturing process development through technical input, experimental design, and definition of control strategies and specifications.
• Lead regulatory inspection readiness and represent the team during audits.
• Ensure all team activities comply with applicable quality standards and the Quality Management System.

Qualifications

• Degree (or higher) in Engineering or a relevant scientific discipline, with experience in an R&D or technical environment.
• Proven experience managing and leading technical teams, ideally within pharmaceutical or combination product development.
• Strong experience supporting regulatory submissions and leading teams during inspections (e.g., FDA or notified bodies).
• Working knowledge of relevant quality and design control standards (e.g., ISO 13485, FDA 21 CFR Part 820).
• Excellent communication, leadership, and stakeholder management skills, with the ability to convey complex technical information clearly.
• Demonstrated problem-solving ability, strong organizational skills, and the ability to perform effectively in a fast-paced environment.