Assistant Manager

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