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Job Description

Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG

Location: Cambridge, MA

About the role:

As a Process Scientist - Global Manufacturing Science GMSci DP/PKG, you will provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing. You will serve as the SME for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products. You will also provide leadership for regulatory interactions including CMC content for dossiers. You will ensure process knowledge is shared and leveraged across sites and functions Serves as Takeda’s global DP SME for issue resolution as needed.

How will you contribute:

• Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units:

• o    Drug Product Manufacturing Process Characterization.

• o    Technology Transfer to both CMOs or internal manufacturing facilities.

• o    Drug Product manufacturing and packaging process validation.

• o    Serves as the experts for deployment as rapid response teams to serve all local manufacturing Operating Units.

• Manage projects within Takeda product portfolio, both development and commercial, to sup-port Manufacturing Sciences DP and Packaging Science activities.

• Implement or provide input for strategies for the continuous improvement on the manufacturing of Marketed Products (a.k.a. matured products) in the late phase of the product life cycle), implement or provide input the manufacturing strategy for key Takeda products at internal manufacturing network and CMOs.

• Accountable for successful collaboration with 

• o    Other functions within GMS.

• o    Manufacturing Operating Unit Site leads.

• o    Local Technical Services functions.

• o    Pharmaceutical Sciences counterparts.

• o    Other key functional groups such as Global Quality, Regulatory CMC, etc.

• SME for Takeda drug product manufacturing organization and network.

• In depth and broad understanding of drug product manufacturing technologies for solid oral dosage form or injectable products

• Knowledge of industry’s best practice and innovative/emerging technology with manufacturing of drug product. Good grasp (Sr Professional) of industry’s standard practices.

• Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs to drive decisions, alignment, and conflict resolution for complex cross-functional issues

• Effectively communicate and implement innovative and emerging technology for drug product within the Manufacturing Sciences organization.  

• Able to communicate and influence decisions of Pharmaceutical Sciences development organization .

• Able to independently make complex and key decisions impacting drug product manufacturing organizations.

• Active engagement with development product implementation prior to commercialization to ensure successful commercialization of key Takeda products. 

• Actively partner with local Technical Services lead to ensure consistent application of best technology 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 of innovative technology at Local Technical Services organizations.

• Manages with a matrix of reporting lines and across functional areas

• Provides leadership to drive highly complex projects including that span multiple sites and products.

What you bring to Takeda:

• BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline with 15+ years of industrial experience or equivalent.  

• Minimum 10 years experience in pharmaceutical development and manufacturing.

• Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturing.

• Focusing on the few priorities and provide superior results.

• Elevating capabilities for now and the future.

• Proficiency in dealing with ambiguity.

• Comfort with complexity and change.

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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:

$153,600.00 - $241,340.00

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

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