Baxter International
Lessines, Belgium
Description
The Technical Operations at Baxter is a group of experts that develop process improvements and provides scientific & technical expertise to the facility manufacturing operations. Focus areas are achieving higher process yields, improving the process robustness, performing quality assessments and leading complex investigations. The Technical Operations group also works closely with Process Science (R&D) groups for the implementation and transfer of new technologies into the regular manufacturing.
PURPOSE OF THE JOB
The Manufacturing Science Lead for fractionation manages process improvements and process robustness initiatives. He seeks to improve the fractionation processes and helps to resolve upcoming issues. He participates in the facility meetings related to the manufacturing operations and quality review meetings. 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 ensures that Exception Reports related to fractionation processes are investigated and closed in a timely manner with adequate corrective and preventive actions implemented. On a continuous basis, he tracks and analyzes manufacturing yields and the critical process parameters. He also works with the Process Science (R&D) and other Technical Operations (TO) groups for the implementation and transfer of new technologies into the regular manufacturing. The Manufacturing Science Lead also ensures that the validation support related to equipment and process validation, cleaning validation and material qualification topics in accordance to the Baxter validation approach and guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develops and manages all projects that will improve yields, throughput & process efficiency and/or will reduce process variations related to the Baxter Plasma fractionation process conducted at Sanquin
- Assesses and improves the fractionation production process robustness and reviews all process related changes from a technical point of view to avoid any potential product or compliance impact.
- On a continuous basis, tracks and investigates yields, process efficiencies and process variability.
- Organizes risk analyses for existing bulk manufacturing processes as well as for new/ugraded processes (Capacity increase, Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks.
- Provides support to ensure that process and equipment validation with a link to process (including computerized systems) and the material qualification is conducted in agreement with the Baxter validation procedures and guidelines.
- Promotes the use of 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.
- Promotes the QBD approach and ensures integration into the process control and change control systems.
- 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 (including defending during FDA audits) for compliance of treated deviations and studies with 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 BioChemistry
- Min. 5 years (including people management experience) in Pharmaceuticals & Bio-therapeutics
- Specific competencies: Lean/Six Sigma and DMAIC methods, knowledge of analytical technologies, statistical data analysis
- Fluent in English
- Technical writing in preparation of regulatory submission files
- Problem solving
- Validation of (bio)pharmaceutical processes
- Protein separation and purification technologies
- Blood protein purification & fractionation