Associate Director, Manufacturing Science for Plasma Drug Substance, Japan New Plasma Facility

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Job Description

ABOUT TAKEDA

We are seeking a highly skilled and motivated Plasma Manufacturing Process Scientist to join our team. As a Process Scientist, you will play a crucial role in the successful tech transfer of plasma processes and products to our new plasma facility in Japan. Reporting to the Head of Manufacturing Science, you will be responsible for driving process validation strategies and ensuring the robustness and reliability of our manufacturing processes. This includes oversight of fractionation, purification, and fill-finish processes which are critical to plasma product manufacturing. Join our team and contribute to the advancement of plasma manufacturing processes in Japan!

Responsibilities

1. Collaborate closely with pharma science, regulatory, and quality control organizations, as well as process experts across our global plasma network.
2. Provide leadership and guidance to team members, assisting them in prioritization, problem resolution, and process clarification.
3. Direct the effective transfer of technology from design development to implementation.
4. Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor.
5. Ensure successful product technical transfer to the new plasma facility.
6. Establish reliable yield status and accurate yield forecasts for all transferred products, implementing strategies to meet yield targets.
7. Develop and direct strategies for yield improvement projects, lead time reduction, process security, and deviation reduction.
8. Assure process robustness and supply reliability by controlling the manufacturing process life cycle.
9. Develop strategic plans that incorporate regional and global business practices and customer needs.
10. Define and communicate strategic imperatives for project success, including market entry timing, innovative technology, and costs.
11. Develop effective tech transfer project milestones, schedules, and manage budgets.
12. Utilize state-of-the-art project management tools to ensure project schedules and budgets are met.
13. Identify and resolve issues that may impact project schedules or improve project time.
14. Understand and effectively communicate market niche and competitive forces influencing the project.
15. Ensure team objectives align with key tech transfer projects for the new facility.
16. Proactively prioritize and balance resource utilization for the project.
17. Select, develop, and retain staff, providing constructive feedback, recognition, coaching, mentoring, and motivation.
18. Generate innovative solutions to complex problems using multiple disciplines and technical principles.
19. Create innovative products, processes, and methods through novel combinations of expertise within the organization.
20. Perform other duties as assigned.

Qualifications

1. Utilize your strong scientific background to contribute to the development and optimization of plasma manufacturing processes.
2. Apply your knowledge of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods to ensure compliance and continuous improvement.
3. Demonstrate self-motivation, strong interpersonal skills, and the ability to analyze and solve complex problems through innovative thought and experience.
4. Utilize project management tools to effectively manage multiple cross-functional teams simultaneously.
5. Design and implement projects/studies outside your area of expertise, leveraging your scientific knowledge and skills.
6. Provide strategic leadership and supervision to ensure the success of process development and tech transfer projects.
7. Utilize your experience in change management to drive process improvement initiatives.
8. Demonstrate a high level of customer orientation and organizational skills.
9. Embrace a flexible and innovative mindset, thinking outside the box to drive continuous improvement.
10. Communicate effectively, both verbally and in writing, to convey complex scientific concepts and project updates.
11. Leverage your record of success in process development, tech transfer, project management, and regulatory submissions to drive the success of our plasma manufacturing processes.
12. Collaborate with cross-functional teams in a highly matrixed, cross-functional, and geographically dispersed environment.
13. Utilize your experience in GMP inspections to ensure compliance with regulatory requirements.

Education and/or experience

1. Bachelor's degree in a science-related field required; Master's or PhD degree in a technical/scientific education, preferably biochemistry, biotechnology, or pharma, is preferred.
2. At least 5 years of professional experience in a similar role in the field of Technical Operations, Process Management, or Manufacturing within the pharmaceutical industry, with significant experience in fractionation, purification, and fill-finish processes.
3. Excellent verbal, written, and interpersonal communication skills in English and Japanese.
4. Ability to build relationships, influence, and drive organizational engagement in a highly matrixed, cross-functional, and geographically dispersed environment.
5. Strong knowledge and application of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods.
6. Proven experience in process development, tech transfer, project management, and regulatory submissions.

Physical Demands

• Must be able to lift, push, pull and carry manufacturing equipment/tools up to 15kg.35 lbs.
• 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

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