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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

As an Associate Director, External Manufacturing & Supply, Cell Therapies, you will 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 leader