Baxter International
Lessines, Belgium
Description
The Manufacturing Science Lead (Formulation & Finishing) develops improvements and establishes different process robustness initiatives related to the formulation, the filling and finishing activities. He leads risk analyses for existing manufacturing processes as well as for new/upgraded processes. He leads cross-functional groups, evaluates possible actions to mitigate/reduce the effect of the identified risks, and ensures the follow-up of the implementation of the actions. He handles Exception Reports related to formulation/finishing manufacturing processes and ensures that adequate investigations are conducted in a timely manner. On a continuous basis, he tracks and analyzes process performance.
Responsabilities:
- Develop and lead projects that will improve the process robustness to reduce process variations.
- Assesses and improves the formulation/finishing process robustness.
- Conduct risk analyses for existing manufacturing processes as well as for new/ugraded processes (Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks.
- Uses Lean, Six Sigma and DMAIC methods as appropriate to better understand and improve the manufacturing processes and to determine the causes of product failures or process shifts.
- Establishes the QBD approach and implements new technologies, including PAT (Process Analytical Technology) techniques to improve the production process control.
- Accountable/responsible for the adequate deployment, implementation and utilization of all quality systems as defined by Baxter Procedures within his organization. Ensure a thorough and timely handling of associated tasks and activities.
- Accountable/responsible for the Compliance to cGMP’s, GDP’s, Licenses and Baxter Procedures within his organization by defining, implementing and maintaining appropriate SOP’s and training.
- Favors communication, critical thinking, problem solving and team work across all manufacturing facilities
- Support the manufacturing team to improve process knowledge through Scientific & Technical trainings.
Qualifications
- Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or Microbiology
- Min 5 years experience in Pharmaceuticals & Bio-therapeutics
- Knowledge of Lean, Six Sigma and DMAIC methods
- Knowledge of analytical technologies
- Excellent skills in statistical data analysis
- Proven experience in technical writing in preparation of regulatory submission files
- Problem solving orientation
- Project management experience
- Good knowledge of English