Requirements: English
Company: Takeda Pharmaceutical
Region: Lessines , Wallonia
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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 cGMPs, GDPs, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOPs 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 cGMPs, GDPs, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOPs 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