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.