By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout 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 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 SummaryWe 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:USA - MA - CambridgeU.S. Base Salary Range:$149,100.00 - $234,300.00The 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 StatementTakeda 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.LocationsUSA - MA - CambridgeWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time