(Senior) Manager, Combination Products and Device Manufacturing

Role Summary

(Senior) Manager, Combination Products and Device Manufacturing — Cambridge, MA. Manage and provide project and technical leadership for manufacturing and lifecycle management of commercial combination products and devices. Act as SME, leading technical transfer and validation projects, optimizing manufacturing processes, and serving as primary technical contact for internal and external device manufacturing sites.

Responsibilities

• Serve as expert on combination products manufacturing process and technologies.
• Lead activities including:
  • Combination products and device manufacturing process characterization.
  • Technology transfer to CMOs or internal facilities.
  • Manage key vendor relationships across multiple projects.
  • Provide technical support to rapid response teams to address urgent challenges and ensure operational continuity.
• Manage multiple development and commercial projects to support Manufacturing Sciences combination products and device science activities.
• Implement continuous improvement strategies for manufacturing of commercial products and lifecycle management.
• Collaborate with R&D, Quality, Regulatory, Procurement, and external suppliers to ensure seamless device lifecycle management and supply continuity.
• Own and manage end-to-end change control process.
• Act as SME for the combination products and device manufacturing organization.
• Demonstrate deep understanding of combination products and device manufacturing technologies for injectable products.
• Apply industry best practices and emerging technologies; lead innovation initiatives.
• Lead cross-functional teams and influence stakeholders to drive alignment and resolve complex issues.
• Communicate and implement innovative technologies within Manufacturing Sciences; make key decisions impacting manufacturing.
• Engage with Product Operations Lead, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity.
• Partner with Local Technical Services to ensure best manufacturing practices across Takeda network.
• Ensure knowledge sharing across sites and functions; maintain current industry knowledge and regulatory strategies.
• Drive and implement innovative technologies at Local Technical Services organizations.
• Manage within a matrix of reporting lines; lead highly complex projects across sites and products.

Qualifications

• Graduate degree in Mechanical, Biomedical Engineering, Material Science, or related field; 10+ years of industrial experience (PhD preferred).
• Experience as a team lead in a matrix environment relating to combination products and device manufacturing.
• Strong understanding of design control and regulatory requirements (FDA, EMA, ISO, USP) for combination products and devices.
• Experience in injection molding; proficiency in CAD/CAM software (e.g., SolidWorks) preferred.
• Strategic thinking, patient-centric mindset, and ability to inspire teams.
• Ability to focus on priorities and deliver superior results; adaptable to dynamic, matrixed environments.
• Strong problem-solving, interpersonal, and cross-functional collaboration skills.