Director, Combination Product Commercialization

Director, Combination Product Commercialization

The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.

Strategic Leadership and Project Management :

• Provide leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally.
• Develop and execute strategic plans for technology transfer, problem-solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
• Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.

Technical Expertise :

Stakeholder Collaboration and Communication :

Team Management and Development :

Regulatory Compliance and Quality Assurance :

Qualifications :