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Job Description

About the role:

As the Manufacturing Science Specialist II, you will handle large and complex investigations related to manufacturing processes and ensures that adequate impact assessment are defined and preventive/corrective actions are implemented in a timely manner. You will defend in front of the regulators and investigations and impact assessment topics. You will identify and develop process improvements and process robustness initiatives and ensure implementation, including the submission preparation. You will lead risk analysis for new, existing and upgraded manufacturing processes. You will lead cross-functional groups (also with other facilities), evaluate possible actions to mitigate and reduce the effect of the identified risks, and ensure follow-up of the implementation of actions.

How you will contribute:

• Handles complex investigations related to manufacturing operations.
• Use Six Sigma and DMAIC methods where appropriate.
• Define tasks/experiments to be performed, provide required documentation and ensure also that adequate corrective actions are implemented to address the identified root-cause(s).
• Ensure and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization.

• Ensure and defend the Compliance to cGMP’s, GDP’s, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOP’s and training.

• Defend investigations in front of regulators during audits

• Develop and lead projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations.

• Use QbD, Six Sigma, Lean and implements new technologies (including PAT) where appropriate.

• Conduct risk analysis for existing manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request), evaluate and implement actions to mitigate/reduce the identified risks.

• Define tasks and experiments to be performed, provide required documentation and lead the project from start to the implementation, including the submission preparation.

• Ensure and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization.

• Participates in technology transfers, CMO related activities and develops and implements solutions for the process.

• Support manufacturing operations on a daily basis and ensures training of personnel on Scientific & Technical topics

• Make decisions related to the organization of the Process Science activities, including document writing, data review, DoE with internal/external lab, order of studies/testing related to Process Science activities

What you bring to Takeda:

• Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience
• GMP and bioprocessing knowledge and experience
• Experience with Technical writing (in English) in preparation of regulatory submission files and defending topics during an FDA or cGMP audit
• QbD, Lean, Six Sigma and DMAIC methods as appropriate

What Takeda can offer you:

We want our employees to succeed in everything they do – at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.

We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

• Generous Time Off: 20 days of paid vacation in accordance with Belgian legislation and 12 Working Time Recovery days with additional days granted based on seniority and age.
• Health & Wellbeing: Comprehensive health and hospitalization insurance, annual check-ups starting at age 45, and support for preventive healthcare.
• Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
• Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
• Transportation & Eco-Benefits: Contributions for public transport, incentives for cycling, and on-site charging stations for electric vehicles.
• Additional Perks: Meal vouchers, eco-cheques, a flex plan, a 13th-month salary, and pension support.

Important Considerations:

At Takeda, our patients rely on us to create quality products, and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, hot environment and load manual handling.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals and biologicals products that may require specific protection (respiratory, skin, etc.).

More About Us:

The Takeda Lessines manufacturing site plays a vital role in the production of Takeda’s plasma-based therapies. With over 75 years of pioneering legacy, Takeda is a global leader in rare diseases and ranks in the top three for plasma-derived products. Our Lessines manufacturing site is a state-of-the-art biotechnology production facility with over 50 years of experience, specializing in immunoglobulin purification, plasma-derived therapies, and packaging for treatments targeting blood disorders. Serving more than 250,000 patients worldwide, we are dedicated to delivering high-quality therapies that make a significant impact. As Takeda's third-largest global production site, Lessines plays a pivotal role in our international operations, producing and distributing million vials annually to more than 80 countries.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you 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. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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