Associate Director or Manager, Manufacturing Operational Excellence, Japan New Plasma Facility Program

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Job Description

About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

Summary

We are seeking a highly skilled and motivated individual for the role of Manufacturing Operational Excellence Manager for Production Readiness at our new Osaka plasma project. This role is responsible for the strategic planning, execution, monitoring, and continuous improvement of all operational readiness activities. The successful candidate will work closely with engineering, manufacturing science, supply chain, and DD&T groups to ensure the production e-Tools and Manufacturing Execution System (MES) are prepared for the facility's launch. Key responsibilities include the development of procedures, training programs, production scheduling tools, and batch records, as well as supporting cleaning, sterilization, and process validation activities in production.

Essential Duties and Responsibilities

• Lead the planning and execution of operational readiness activities, including the development of procedures, training programs, production scheduling tools, and batch records.

• Collaborate with engineering, manufacturing science, supply chain, DD&T, and quality groups to ensure seamless integration and readiness of production e-Tools and MES.

• Implement a continuous improvement framework to evaluate and enhance the effectiveness of operational readiness activities.

• Coordinate and support execution readiness activities for cleaning, sterilization, and process validation in the production environment.

• Monitor the progress of operational readiness activities, ensuring adherence to timelines and quality standards.

• Develop and execute a robust checking mechanism to ensure that all operational readiness components meet the required specifications and regulations.

• Facilitate cross-functional communication to align operational readiness efforts with overall facility goals.

Qualifications

• Demonstrated expertise in operational excellence and readiness within a plasma manufacturing environment, with a strong understanding of industry principles, methodologies, and tools.

• Proven track record of successfully managing complex, large-scale readiness initiatives in a regulated plasma manufacturing environment.

• Strong leadership capabilities, with experience in guiding cross-functional teams and interfacing with engineering, manufacturing science, supply chain, DD&T and quality groups.

• Strategic thinker with the ability to bring structure to complex problems and devise effective readiness strategies.

• Excellent communication skills, both written and oral, capable of conveying complex readiness plans and activities in a clear and actionable manner.

Education and/or experience

• Advanced degree in engineering or science (e.g., Master of Science) is required.

• At least 7 years of experience in the life sciences industry, with a minimum of 5 years in operational roles focused on manufacturing operational readiness or similar functions.

• Program Management Professional (PMP) certification is preferred, as is Six Sigma or Lean certification.

• Experience with facility start-up program, qualification & validation execution, Manufacturing Execution Systems (MES) and production e-Tools development is highly desirable.

Physical Demands

• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment. Will work in a cold, wet environment. Must be able to work overtime as required (APPLICABLE TO SNE only). May be required to work in a confined area. Some clean Room and cool/hot storage conditions.

Other Job Requirements

• ​ Availability to travel as needed to coordinate with various stakeholders and to receive specialized training & benchmarking.

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

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