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Job Description

Job Title: Process Scientist Lead - Global Manufacturing Science Drug Product

Location: Cambridge, MA

About the role:

• Provide technical expertise within the GMSci Drug Product (DP) Packaging organizations relating to manufacturing technology and sciences for drug product manufacturing.
• Serves as the SME for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products
• Provides leadership for regulatory interactions including CMC content for dossiers
• Ensures process knowledge is shared and leveraged across sites and functions
• Serves as Takeda’s global DP SME for issue resolution as needed

How you will contribute:

• Serves as Takeda’s expert on small molecule OSD or parenteral process and technologies
• Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units:
  • Drug Product Manufacturing Process Characterization,
  • Technology Transfer to both CMOs or internal manufacturing facilities,
  • Drug Product manufacturing and packaging process validation
  • 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 support Manufacturing Sciences DP and Packaging Science activities
• Implement 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 the manufacturing strategy for key Takeda products at internal manufacturing network and CMOs
• Accountable for successful collaboration with
  • Other functions within GMS
  • Manufacturing Operating Unit Site leads
  • Local Technical Services functions
  • Pharmaceutical Sciences counterparts
  • Other key functional groups such as Global Quality, Regulatory CMC, etc.

Associate Director level

• Provides above leadership for multiple Takeda key products.

Technical/Functional (Line) Expertise

• 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.

Leadership

• 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

Decision-making and Autonomy

• Make complex and key decisions impacting drug product manufacturing organizations.

Interaction

• 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

Innovation

• 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

Complexity

• 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:

Education / experience

• BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline
• Minimum 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

Skills

• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

Behaviors

• Focusing on the few priorities and provide superior results
• Elevating capabilities for now and the future

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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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.

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