Senior Executive

RESPONSIBILITIES :

• Complete technical / scientific understanding on purification / downstream process of biopharmaceutical products
• Expertise in downstream process lab scale / pilot scale / manufacturing scale equipment handling e.g., chromatography system, TFF system, filtration process, centrifugation, etc.
• Knowledge of execution of small-scale purification process using scale down model. Handling and working knowledge of lab instruments e.g., UV spectroscopy, Solo VPE, pH and conductivity meter, turbidity meter.
• Knowledge of downstream process scale-up strategies
• Process data collection, basic data analysis skill.
• Effectively work and communicate with team, CFTs and partners for planning and execution of downstream process improvement activities and formulation / review / revision of procedural controls and procedures in the processes and its implementation in the manufacturing process.
• Authoring / reviewing of process / QMS / process part of regulatory filing documents. Participate in cross-functional root cause analysis discussions and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, and CAPA).
• Follow and adhere to rules, regulations and procedures, data integrity and compliance in performing the assigned activities.
• To perform responsibilities of Departmental Training Coordinator such as management and effectiveness of trainings in MSAT group.