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Job Description

Job Title: Cell Bank Program Manager

Location : Lexington, MA (USA)

About the role:

As the Program Manager (PM), you will work with the Head of Takeda's Global Cell Bank Center of Excellence (CoE) to provide management and oversight of the Cell Bank CoE project portfolio and 5-year strategic roadmap. You will support relevant Takeda site, Operating Unit, and company objectives, and engage in business development opportunities, manage individual 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 recurring global CoE governance meetings. You will report to the Head of Cell Bank Manufacturing & COE.

How you will contribute:

• Lead and support project teams in defining program strategies and goals, and assigns/manages project tasks as applicable to meet Cell Bank CoE objectives.

• Management of CoE Governance meetings and strategic alignment to Cell Bank CoE Network Operational model

• Increase Cell Bank site capacity and capability to support Takeda's Biologics pipeline of programs.

• Work with cross-functional 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.

• May work with 3rd party CMOs or CTLs to support compliant manufacture, release, testing, or storage of externally managed cell bank activities.

• Support 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.

• Help prioritization and execution of cell bank decommissioning activities.

• Support Cell Bank Tech Transfers for internal and external activities and support capital projects.

• Develop and manage projects and processes as they relate to continuous improvement projects for Manufacturing Operations

• Plan for local and/or global Change Controls with applicable stakeholders.

• Bridge technical and business disciplines as they relate to cell banking activities.

• Anticipate functional resource requirements and gains commitment from functional stakeholders for resource participation on key initiatives.

• Manage contract project resources and mentoring junior employees as applicable.

• Support establishment of annual department and CoE goals according to local and global requirements.

What you bring to Takeda:

• Bachelor's degree or equivalent experience in Engineering or Science and 10+ years of relevant experience in commercial biotechnology or pharmaceutical production managing projects and schedule development is required.

• PMP certification is desirable.

• Knowledge of cGMPs, CMC, inventory and compliance systems (e.g. SAP, Trackwise) and applicability to manufacturing operations in a biologics or API environment would be ideal.

• Prior experience troubleshooting, risk assessment and mitigation.

• Comfortable making risk-based recommendations based on science, data, or relevant experience.

• Experience presenting to all levels within an organization

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.

• Candidate will be required to carry a cellular device and be available to support production requirements as appropriate.

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.

#GMSGQ #ZR1 #LI-MA1

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.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time