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, align with therapeutic programs, 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 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 human factors 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

• Associate Director: 10+ years of experience in the pharmaceutical or medical device industry or equivalent
• Director: 12+ years of experience in the pharmaceutical or medical device industry or equivalent

Skills

• Technical leadership in device development, packaging, and accessory development
• Regulatory documentation and compliance proficiency
• Project leadership and cross-functional collaboration
• Quality risk management and design controls

Education

• Bachelors degree in Science, Engineering, or related discipline

Additional Requirements

• None specified