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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 regulatory requirements (FDA, EMA, ISO, USP) for combination products and devices.
Previous experience in injection molding, and proficiency in CAD/CAM software (e.g., SolidWorks) is preferred.
Strategic enterprise thinking, finding innovative ways to serve patients, build reputation, and trust.
Creating an environment that inspires and enables people.
Focusing on the few 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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
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.
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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
