TAKEDA PHARMACEUTICALS AMERICA, INC.
(Senior) Manager, Combination Products and Device Manufacturing
TAKEDA PHARMACEUTICALS AMERICA, INC., Boston, Massachusetts, us, 02298
Senior Manager, Combination Products and Device Manufacturing
Location: Boston, Massachusetts
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 support deviations and investigations, and you will serve as the 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.
Key Responsibilities
Serve as Takeda’s expert on combination products manufacturing processes and technologies.
Lead the following activities:
Combination products and device manufacturing process characterization.
Technology transfer to both CMOs and internal manufacturing 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 projects within Takeda’s product portfolio, both development and commercial, to support Manufacturing Sciences Combination Products and Device Science activities.
Implement strategies for continuous improvement in 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.
Act as the SME for Takeda’s combination products and device manufacturing organization.
Demonstrate an in‑depth and solid understanding of combination products and device manufacturing technologies for injectable products.
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 the Manufacturing Sciences organization.
Make key decisions impacting combination products and device manufacturing independently.
Partner with Product Operations Lead, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity of key Takeda products.
Collaborate with Local Technical Services lead to ensure consistent application of best manufacturing practices across the Takeda network.
Ensure process knowledge sharing across sites and functions for effective management of products.
Maintain current industry‑leading technology knowledge, scientific approach, and regulatory strategies.
Drive and implement innovative technologies at Local Technical Services organizations.
Manage a matrix of reporting lines and across functional areas.
Provide 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 related discipline with 10+ years of industrial experience (PhD preferred).
Prior experience serving 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 and proficiency in CAD/CAM software (e.g., SolidWorks) preferred.
Strategic enterprise thinking, focusing on innovative ways to serve patients and build reputation and trust.
Ability to create an environment that inspires and enables people, focusing on priorities and providing superior results.
Elevating capabilities for now and the future.
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.
Compensation and Benefits Summary U.S. base salary range: $137,000.00 – $215,270.00. The actual base salary offered may depend on a variety of factors including qualifications, experience, and location. Employees may be eligible for short‑term and/or long‑term incentives and a comprehensive benefits package including medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, and wellness benefits. U.S. employees are eligible for up to 80 hours of sick time annually and, for new hires, up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Employee Details
Seniority level: Director
Employment type: Full‑time
Job function: Product Management and Marketing
Industries: Pharmaceutical Manufacturing
Worker Type: Employee
Worker Sub‑Type: Regular
Time Type: Full time
Job exempt: Yes
Apply To apply, please submit your application through our careers portal.
#J-18808-Ljbffr
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 support deviations and investigations, and you will serve as the 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.
Key Responsibilities
Serve as Takeda’s expert on combination products manufacturing processes and technologies.
Lead the following activities:
Combination products and device manufacturing process characterization.
Technology transfer to both CMOs and internal manufacturing 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 projects within Takeda’s product portfolio, both development and commercial, to support Manufacturing Sciences Combination Products and Device Science activities.
Implement strategies for continuous improvement in 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.
Act as the SME for Takeda’s combination products and device manufacturing organization.
Demonstrate an in‑depth and solid understanding of combination products and device manufacturing technologies for injectable products.
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 the Manufacturing Sciences organization.
Make key decisions impacting combination products and device manufacturing independently.
Partner with Product Operations Lead, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity of key Takeda products.
Collaborate with Local Technical Services lead to ensure consistent application of best manufacturing practices across the Takeda network.
Ensure process knowledge sharing across sites and functions for effective management of products.
Maintain current industry‑leading technology knowledge, scientific approach, and regulatory strategies.
Drive and implement innovative technologies at Local Technical Services organizations.
Manage a matrix of reporting lines and across functional areas.
Provide 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 related discipline with 10+ years of industrial experience (PhD preferred).
Prior experience serving 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 and proficiency in CAD/CAM software (e.g., SolidWorks) preferred.
Strategic enterprise thinking, focusing on innovative ways to serve patients and build reputation and trust.
Ability to create an environment that inspires and enables people, focusing on priorities and providing superior results.
Elevating capabilities for now and the future.
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.
Compensation and Benefits Summary U.S. base salary range: $137,000.00 – $215,270.00. The actual base salary offered may depend on a variety of factors including qualifications, experience, and location. Employees may be eligible for short‑term and/or long‑term incentives and a comprehensive benefits package including medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, and wellness benefits. U.S. employees are eligible for up to 80 hours of sick time annually and, for new hires, up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Employee Details
Seniority level: Director
Employment type: Full‑time
Job function: Product Management and Marketing
Industries: Pharmaceutical Manufacturing
Worker Type: Employee
Worker Sub‑Type: Regular
Time Type: Full time
Job exempt: Yes
Apply To apply, please submit your application through our careers portal.
#J-18808-Ljbffr