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Job Description

Title: Senior Manager, Combination Products and Device Manufacturing

Location: Cambridge, MA

About the role:

As a Senior Manager, Combination Products and Device Manufacturing, you will manage and provide project and technical leadership for manufacturing and lifecycle management of commercial combination products and devices. You will serve as the subject matter expert (SME), leading major technical transfer and validation projects related to new product introduction or life cycle management of existing products. You will lead the optimization of manufacturing processes and lead or support deviations and investigations. Additionally, you will serve as a primary technical point of contact for both internal and external device manufacturing and assembly sites to ensure process knowledge is effectively shared and leveraged across sites and functions.

How will you contribute:

• Serve as Takeda’s expert on combination products manufacturing process and technologies.

• Lead the following activities:

  • Combination products and device manufacturing process characterization.

  • Technology transfer to both CMOs or internal manufacturing facilities.

  • Manage key vendor relationships across multiple projects.

  • Provides technical support to rapid response teams to address urgent challenges and ensure operational continuity.

• Manage multiple projects within Takeda product portfolio, both development and commercial, to support Manufacturing Sciences Combination Products and Device Science activities.

• Implement strategies for the continuous improvement on the manufacturing of commercial products and lifecycle management activities.

• Work closely with R&D, Quality, Regulatory, Procurement, and external suppliers to ensure seamless device lifecycle management and supply continuity.

• Own and manage the end-to-end change control process.

• SME for Takeda combination products and device manufacturing organization.

• In depth and solid understanding of combination products and device manufacturing technologies for injectable products.

• Expert in industry best practices and emerging technologies for combination product and device manufacturing, with experience leading innovation initiatives.

• Lead cross-functional teams and effectively influence key stakeholders—including Pharmaceutical Sciences, Plasma Derived Therapies R&D, GMS Operating Units, and CMOs—to drive alignment, decision-making, and resolution of complex issues.

• Champion the communication and implementation of innovative and emerging technologies for combination product and device manufacturing within the Manufacturing Sciences organization. 

• Able to independently make key decisions impacting combination products and device manufacturing.

• Active engagement with Product Operations Lead, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity of key Takeda products.

• Actively partner with local Technical Services lead to ensure consistent application of best manufacturing practices across Takeda network.

• Ensures process knowledge sharing across sites and functions for effective management of products.

• Maintain current industry leading technology knowledge, scientific approach and regulatory strategies.

• Ability to drive and implement innovative technologies at Local Technical Services organizations.

• Manages with a matrix of reporting lines and across functional areas.

• Provides leadership to drive highly complex projects that span multiple sites and products.

What you bring to Takeda:

• Graduate degree in Mechanical, Biomedical Engineering, Material Science or other related discipline with 10+ (Sr Manager) years of industrial experience or equivalent. (PhD degree preferred). 
• Previous experience in serving as a team lead in a matrix environment relating to combination products and device manufacturing.
• Strong understanding of design control and regulator