Takeda · 2 months ago
Senior/Principal Engineer, Combination Products and Drug Delivery Devices
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expTakeda is a leading biopharmaceutical company, and they are seeking a Senior/Principal Engineer specializing in Combination Products and Drug Delivery Devices. The role involves managing project and technical leadership for the development and lifecycle management of parenteral drug delivery systems, collaborating with R&D, and optimizing manufacturing processes.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
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
Preferred
PhD degree preferred
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
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
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