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Job Description

About the role:

As an Associate Director, External Manufacturing & Supply, Cell Therapies, youwill manage an external manufacturing network to support the Takeda cell therapy portfolio. The scope of the role includes providing technical support for routine manufacturing operations, process improvements, lifecycle management and technical transfers of Takeda processes to the CMO manufacturing sites. You will also have accountability for developing process qualification, control and comparability strategies and support regulatory submissions for externally manufactured materials. The position will lead Takeda’s strategy to develop internal viral vector manufacturing capabilities and manage a viral vector manufacturing team.

How you will contribute:

• Oversight of Contract Manufacturing Organizations (CMOs) for critical materials - viral vectors plasmids, cell lines and excipients

• Deliver schedule adherence, material forecasting, and supply of materials from CMOs and internal viral vector manufacturing campaigns

• Drive the External manufacturing excellence and technology transfer, validation, qualification and comparability strategies

• Provide technical and quality guidance to external partners in collaboration with Takeda SMEs. Support root cause analysis and product impact assessments for investigations resulting from deviations and OOS events

• Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression

• Work closely with CMO and internal Quality and Technical teams to complete investigations and deviations. Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs

• Support data-driven insights into compliance performance and explore opportunities for improvement

• Engage internal and external stakeholders for change management, issue resolution and adherence to agreed deliverables.

• Work closely with the Quality Compliance and Supplier Quality function to establish the audit strategy for Auditing and Supplier Performance monitoring and support technical site audits, including preparation for regulatory inspections

• Oversee CMO execution and performance, conducting regular monitoring and gathering data to enable robust Supplier Relationship Management (metrics, KPIs).

• Plan and manage future supplies and safety stocks for cell banks and critical materials used in viral vector manufacturing

• Collaborate with Quality to ensure GMP practices are followed by external partners and implement appropriate controls and liaison for Quality release.

Minimum Requirements/Qualifications:

• Bachelors degree or higher in Life Sciences or related discipline, 

• Around 8 years of related experience in biopharmaceutical manufacturing with experience in working with CMOs. Knowledge of viral vector and CMOs essential

• Strong technical knowledge in viral vector manufacturing and ability to manage multiple CDMO relationships and build supply risk mitigation plans

• Experienced people leader, strong leadership and an innate ability to collaborate and build relationships is critical

• Flexible and comfortable working with ambiguity

• Ability to problem-solve and work in complex environment

• Position requires travel 20%

• Good understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA)

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.

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.

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U.S. Base Salary Range:

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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