Job Description

Department Details
Role Summary
RESPONSIBILITIES:
1. Complete technical/scientific understanding on purification/downstream process of biopharmaceutical products
2. Expertise in downstream process lab scale/pilot scale/ manufacturing scale equipment handling e.g., chromatography system, TFF system, filtration process, centrifugation, etc.
3. 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.
4. Knowledge of downstream process scale-up strategies, Technology transfer, regulatory requirements, GxP guidelines
5. Process data collection and intermediate data analysis skill, data interpretation and support for decision making.
6. Performing continued process verification to ensure that the process is under validated state of controls, and it delivers consistent product quality and yield consistently.
7. Evaluate downstream manufacturing process and institute process improvement/optimization, scale-up, tech transfer, debottlenecking and productivity and throughput increase, COGS reduction initiatives and evaluation and implementation of new technologies wherever applicable.
8. 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.
9. 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).
10. Follow and adhere to rules, regulations and procedures, data integrity and compliance in performing the assigned activities.
Key Responsibilities
RESPONSIBILITIES:
1. Complete technical/scientific understanding on purification/downstream process of biopharmaceutical products
2. Expertise in downstream process lab scale/pilot scale/ manufacturing scale equipment handling e.g., chromatography system, TFF system, filtration process, centrifugation, etc.
3. 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.
4. Knowledge of downstream process scale-up strategies, Technology transfer, regulatory requirements, GxP guidelines
5. Process data collection and intermediate data analysis skill, data interpretation and support for decision making.
6. Performing continued process verification to ensure that the process is under validated state of controls, and it delivers consistent product quality and yield consistently.
7. Evaluate downstream manufacturing process and institute process improvement/optimization, scale-up, tech transfer, debottlenecking and productivity and throughput increase, COGS reduction initiatives and evaluation and implementation of new technologies wherever applicable.
8. 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.
9. 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).
10. Follow and adhere to rules, regulations and procedures, data integrity and compliance in performing the assigned activities.
Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 5 - 8 years