Director Combination Product Development

Role Summary

Director of Combination Product Development responsible for providing technical expertise to support and implement the strategic vision for combination products. Drives device and packaging development, ensures alignment with therapeutic programs, and supports clinical and commercial manufacturing. Collaborates with internal teams, external partners, and suppliers to advance device industrialization, regulatory compliance, and operational excellence.

Responsibilities

• Collaborate with Combination Products senior leadership to revamp and execute development strategies.
• Lead technical relationships with alliance partners, device manufacturers, component suppliers, and consultants to ensure alignment and project success.
• Provide technical expertise to guide the development of devices, packaging, and accessories for therapeutic programs.
• Interface with internal teams, alliance partners, and suppliers to ensure effective communication, alignment, and project execution.
• Oversee the creation and maintenance of documentation, including Design History Files, quality engineering data, and usability study results.
• Provide expertise and documentation for regulatory filings, ensuring compliance with device design, manufacturing process controls, and quality risk management standards.
• Support device component manufacturing and clinical/commercial manufacturing of combination products.
• Provide technical support for qualification activities, assembly guidance, process controls, and risk assessments for internal fill-finish manufacturing operations.

Qualifications

• Bachelor’s degree in Science, Engineering, or related discipline.
• Associate Director: 10+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience.
• Director: 12+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience.

Education

• Bachelor’s degree in Science, Engineering, or related discipline.