Director Combination Product Development

Role Summary

Director of Combination Product Development. Provide technical expertise to support and implement the strategic vision for combination products, drive device and packaging development, and support clinical and commercial manufacturing. Collaborate with internal teams, external partners, and suppliers to advance device industrialization, regulatory compliance, and operational excellence.

Responsibilities

• Collaborate with senior leadership to revamp and execute combination product development strategies.
• Lead technical relationships with alliance partners, device manufacturers, component suppliers, and consultants to ensure 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 thorough 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

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

Skills

• Project leadership and team management.
• Regulatory compliance and quality risk management for devices.
• Communication and collaboration with internal and external stakeholders.
• Device development, packaging, and manufacturing processes.

Education

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

Additional Requirements

• Travel and other role-specific requirements not listed in this description.