Associate Director, Manufacturing Science for Plasma Drug Substance, Japan New Plasma Facility
Jūsō-honmachi, ŌsakaOn the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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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.
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
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.
Locations
Osaka (Juso), JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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