Head of Cell Banking Center of Excellence

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Job Description

Job Title: Head of Cell Banking Center of Excellence

Location: Lexington, MA

About the Role:

As the Head of Takeda's Cell Bank Center of Excellence (CoE), you will be responsible for management and oversight of the Cell Bank CoE project portfolio and 5 year strategic roadmap. You will participate in business development opportunities, lead/guide project teams (where applicable) aimed at delivering value for the Cell Bank end-to-end value chain, participate and engage with biopharma industry consortia forums, and coordinate/ facilitate recurring global CoE governance meetings.

You will provide management oversight and administration of Cell Banking Center Of Excellence (COE), including Cell Bank Manufacturing Operations. You will manage the activities of the staff, monitoring the maintenance of equipment and facilities in production, overseeing complete documentation of all required production activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. You will report to the Head of Manufacturing Sciences.

How you will contribute:

• Partner to establish operational capability and flexibility to produce Master and Working Cell Banks and establish Cell Bank as the Center of Excellence for the global network.

• Be a member of the Manufacturing Science Leadership Team, responsible for developing strategic plans that support the goals, objectives and priorities for the cell banking COE organization.
• Oversee the Cell Bank manufacturing area schedule to ensure market and inventory demands are met.
• Develop/Improve business process for Cell Bank Operations and partner with stakeholders and customer to develop a global community of practice
• Provide support for project portfolio management (capital projects and technology transfers) and interdepartmental collaboration to provide continuity between manufacturing plants
• Participate in proactive measure to promote a positive safety culture to ensure zero incidents, injuries, and the protection of people, property and the environment through communications, review of EHS performance metrics and incident reports.
• Champion self-initiated projects and drive area under their control within the context of corporate and functional area priorities; justify goals to senior management and lead cross-functional projects and teams encouraging teamwork to drive project/process improvements.
• Lead project teams in defining program strategies and goals, and assigns/manages project tasks as applicable to meet Cell Bank CoE objectives and manage CoE Governance meetings and strategic alignment to Cell Bank CoE Network Operational model
• Lead in activities to increase Cell Bank site capacity and capability to support Takeda's Biologics pipeline of programs.
• Work with departments including Regulatory, Supply Chain QA, QC, Pharmaceutical Sciences Cell Line Development, MFG, and Finance to maximize efficiency and ensure best practice approaches for the compliant intake, manufacture, qualification, testing, release, storage, transportation, and approval of cell bank supply for clinical and commercial programs.
• Lead establishment of centralized and accessible electronic systems for Cell Bank knowledge management, project, and data analytics.
• Engage with global Supply Chain, product teams, and network sites as applicable to provide information on changing requirements or risks to cell bank inventory or overall product lifecycle.
• Lead Cell Bank Tech Transfers for internal and external activities and support capital projects and supports projects as they relate to continuous improvement projects for Manufacturing Operations.
• Support planning for local or global Change Controls with applicable stakeholders.
• Bridge technical and business disciplines as they relate to cell banking COE activities.
• Participate in facility and process inspections by domestic and international regulatory agencies
• Ensure that all procedures and records are maintained to reflect current manufacturing methods and in conformance with product licenses and that production equipment and facilities are maintained in proper working condition and in a validated state through use quality systems (e.g. change control)
• Ensure submission and completion of all area quality documentation to meet established timelines, compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline and Cell Bank operations align to global quality standards.

What you bring to Takeda:

• BS Degree in Science or Engineering with 8+ years of relevant experiences.
• Record of technical leadership, including motivating and driving technical rigor.
• Knowledge of cGMP and other regulatory requirement related to manufacturing of biologics.
• Experience with people management, including maximizing staff effectiveness, and allocate resources in a dynamic environment..

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.
• Travel approximately 10% - 20% (national and international)

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.

#GMSGQ #ZR1 #LI-MA1

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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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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