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As a Senior/Principal Engineer, Combination Products and Drug Delivery Devices, you will manage and provide project and technical leadership for development, manufacturing and lifecycle management of parenteral drug delivery systems. You will serve as the SME for leading major technical transfer or validation projects relating to new product development, launch or life cycle management. Lead collaborations and interaction with R&D for development and technology transfer of combination products for successful manufacturing within GMS internal and external network. You will lead the optimization of manufacturing process. Lead or assist in deviation, and investigations.
Serve as Takeda’s expert on combination products development, technology transfer, manufacturing, and assembly processes and technologies.
Lead the following activities along with Pharmaceutical Sciences and/or Operation Units:
Combination products and device manufacturing process development, characterization, and optimization including fill/finish, assembly and packaging.
Technology transfer to both CMOs or internal manufacturing facilities.
Manage key internal partners and external vendor relationships .
Serves as the expert for deployment as rapid response teams to serve all local manufacturing Operating Units.
Manage 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.
Provides the above leadership for multiple Takeda products.
SME for Takeda combination products and device manufacturing organization.
In depth and solid understanding of combination products and device manufacturing technologies for injectable products, including PFS/vial fill finish, autoinjector and needle safety device assembly and packaging.
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 drug delivery devices development and 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, and regulatory strategies..
Ability to drive and implement innovative technologies at manufacturing sites.
Manages with a matrix of reporting lines and across functional areas.
Provides leadership to drive highly complex projects that span multiple sites and products.
Graduate degree in Mechanical, Biomedical Engineering, Material Science or other related discipline with 10+ (Principal Engineer), or 5 (Senior Engineer) 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 devices development and manufacturing.
Strong understanding of design control and regulatory requirements (FDA, EMA, ISO) for combination products and devices.
Previous experience in the development and manufacturing of parenteral drug delivery systems—including PFS/vial fill finish, autoinjector, and needle safety device assembly and packaging—is highly preferred.
Self-motivated with strong interpersonal skills; adept at analyzing and solving complex problems through innovative thinking and practical experience.
Demonstrated ability to work independently and collaboratively in cross-functional teams.
Skilled at navigating ambiguity and driving results in a dynamic, matrixed environment.
Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust.
Creating the environment that inspires and enables people.
Focusing on the few priorities and provide superior results.
Elevating capabilities for now and the future.