Takeda · 15 hours ago
Senior/Principal Engineer, Combination Products and Drug Delivery Devices
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff
$137K/yr - $215K/yr
5+ years expTakeda is a leading global biopharmaceutical company, and they are seeking a Senior/Principal Engineer for Combination Products and Drug Delivery Devices. In this role, you will provide project and technical leadership in the development and lifecycle management of parenteral drug delivery systems, ensuring seamless technology transfer and optimization of manufacturing processes.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Serve as Takeda’s expert on combination product development, technology transfer, manufacturing, and assembly processes and technologies
Lead activities in partnership with Pharmaceutical Sciences and/or Operating Units, including Combination products and device manufacturing process development, characterization, and optimization—including fill/finish, assembly, and packaging
Technology transfer to both contract manufacturing organizations (CMOs) and internal manufacturing facilities
Managing key internal partner and external vendor relationships
Providing technical support to rapid response teams to address urgent challenges and maintain operational and supply continuity
Manage multiple projects within the Takeda portfolio, supporting both development and commercial Manufacturing Sciences Combination Products and Device Science activities
Implement strategies for continuous improvement in the manufacturing of commercial products and lifecycle management
Collaborate closely with R&D, Quality, Regulatory, Procurement, and External Supply Teams to support seamless device lifecycle management and supply continuity
Own and manage the end-to-end change control process
Act as the SME for the Takeda combination products and device manufacturing organization
Possess in-depth knowledge of combination products and device manufacturing technologies for injectable products—including PFS/vial fill finish, autoinjector, and needle safety device assembly and packaging
Demonstrate expertise 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 Manufacturing Sciences
Independently make key decisions impacting the development and manufacturing of combination products and drug delivery devices
Engage actively with Product Operations, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity for key Takeda products
Partner with manufacturing sites to ensure consistent application of best manufacturing practices across the Takeda network and facilitate process knowledge sharing for effective product management
Stay current with industry-leading technologies and manufacturing strategies
Drive and implement innovative technologies at manufacturing sites
Manage within a matrixed organizational structure across functional areas
Provide leadership for highly complex projects spanning multiple sites and 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 a related discipline, with 10+ years (Principal Engineer) or 5+ years (Senior Engineer) of relevant industrial experience (PhD preferred)
Prior experience as a team lead in a matrixed environment involving combination product and device development and manufacturing
Strong understanding of design control and regulatory requirements (FDA, EMA, ISO, USP) for combination products and devices
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 within cross-functional teams
Skilled at navigating ambiguity and driving results in a dynamic, matrixed environment
Strategic, enterprise-minded thinker who finds innovative ways to serve patients and build trust
Capable of inspiring and enabling people in a collaborative environment
Focused on key priorities to deliver superior results
Dedicated to elevating capabilities for present and future needs
Preferred
Experience in the development and manufacturing of parenteral drug delivery systems, including PFS/vial fill finish, autoinjector, and needle safety device assembly and packaging
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
2026-01-09
2026-01-08
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