Manufacturing Science Specialist

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Job Description

About the role:

Primary duties:

The Manufacturing Science Specialist has two main areas of work:

Handles large and complex investigations related to manufacturing processes and ensures that adequate corrective actions are implemented in a timely manner. He must also ensure that impacts (process, product) are identified and thoroughly evaluated. He defends such investigations in front of regulators.

Works on process development, improvements and robustness initiatives and leads such projects from start to implementation, including the submission preparation. He leads risk analyses for existing manufacturing processes as well as for new/upgraded processes. He leads cross-functional groups (also with other facilities), evaluates possible actions to mitigate/reduce the effect of the identified risks, and ensures the follow-up of the implementation of the actions.

Responsibilities:

Handles complex investigations related to manufacturing operations. In view of this:

• Uses Six Sigma and DMAIC methods where appropriate.
• Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s).
• Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
• Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOP’s and training.
• Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
• Defends investigations in front of regulators during audits.

Develops and leads projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations. In view of this:

• Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate.
• Conducts risk analyses 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.
• Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation.
• Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
• Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOP’s and training.
• Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
• Defends submissions in the role of recognized process expert.

As a recognized process expert:

• Is involved in technology transfers, CMO related activities
• Ensures training of personnel on Scientific & Technical topics

What you bring to Takeda

Education and Experience Requirements

• Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience.
• 3 to 5 years in Pharmaceuticals & Bio-therapeutics manufacturing, in a similar function
• Honest and responsible, flexible, customer focused, team player, open minded
• Critical thinking and Problem Solving
• 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, DIDOV, Lean, Six Sigma and DMAIC methods as appropriate

Complexity and Problem Solving

Decision related to the organization of the Manufacturing Science activities, including document writing, data review, DoE with internal/external lab, order of studies/testing related to Manufacturing Science activities.

Internal and External Contacts

Contact with internal and external stakeholder for the coordination of Manufacturing Sciences activities (root cause analysis and/or product impact assessment related to deviation, documentation writing, establishment of DoE with testing/sampling at lab or manufacturing scale) ; contact and with external stakeholders (Takeda SME, material/equipment/technology suppliers, lab contractors).
Accountability to the Manufacturing Sciences and MQ Lead, to the Project leads, to the Global MS organization.

Other Job Requirements

• Must be Fluent in English speaking, writing and reading
• Can travel abroad for training, Audit or projects

MORE ABOUT US:

At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented company that will inspire you and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide.

EMPOWERING OUR PEOPLE TO SHINE:

Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law.

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