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Senior Director of Cell Therapy Manufacturing
2 months ago
About the Role:
Takeda Pharmaceutical (US) is seeking a highly skilled and experienced professional to lead our cell therapy manufacturing operations. The successful candidate will be responsible for overseeing the internal manufacturing team, ensuring compliance with regulatory requirements, and developing and implementing strategies for growth and improvement.
Key Responsibilities:
- Responsible for the overall direction and strategy of cell therapy manufacturing operations, including planning, budgeting, and resource allocation.
- Lead a team of experienced manufacturing professionals to ensure efficient and effective operation of manufacturing processes.
- Develop and implement strategies to improve manufacturing efficiency, quality, and compliance with regulatory requirements.
- Collaborate with cross-functional teams to develop and implement new manufacturing technologies and processes.
- Ensure compliance with all regulatory requirements, including FDA and EMA regulations.
- Foster a culture of safety, quality, and continuous learning within the manufacturing team.
- Develop and manage budgets, participate in annual financial forecasting, and ensure adherence to Takeda financial targets.
Requirements:
- B.S., M.S. or Ph.D in Engineering or life science with 15+ years of relevant technical experience in technical development, manufacturing science, or other disciplines in technical operations.
- Previous hands-on experience in a cell therapy cGMP environment is required.
- Experience in design, construction, and set-up/validation of new cell therapy manufacturing facilities is essential.
- Highly familiar with aseptic processing, expansion, and differentiation of cell therapy products, generation of viral vectors, and formulation of cellular therapeutics.
- Previous experience in managing technical interactions with CMOs, manufacturing of cell therapies, or product life cycle management is required.
- Experience in analytical method validation, transfer, and quality control in accordance with regulatory guidelines and industry standards is preferred.
- Experience in supply chain planning, SAP ERP system, supply network strategy, and optimization is preferred.
About Takeda Pharmaceutical (US):
Takeda Pharmaceutical (US) is a global biopharmaceutical company committed to bringing better health and a brighter future to people around the world. We are a patient-focused company that inspires and empowers our employees 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.
Equal Employment Opportunity:
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 other protected characteristics.
