Manager, Manufacturing Operational Excellence

[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.

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.