About the role
1. Technical Responsibilities1.1 Execute and operate upstream manufacturing batch activities1.2 Operate process equipment like fermenter, centrifuge, homogenizer, mixers, autoclave, etc.1.3 Manage vial thaw, cell counting and other seed expansion activities1.4 Manage media preparation and filtration activities1.5 Maintaining Quality Management Systems related documentation like - deviations, change controls, risk assessment documents etc.1.6 Monitoring of batch performance and data1.7 Hands-on experience with SS fermenters1.8 Experience in the equipment qualification and validations1.9 Proper documentation of batches as per SOP and written procedures
2.0 GMP compliance2.1 Apply Good Manufacturing Principles in all areas of responsibility2.2 Follow environment, health, and safety (EHS) requirements in the workplace2.3 Ensuring compliance to cGMP in area as defined by SOPs
3.0 Skills Required3.1 Working in a cGMP environment.3.2 Experience in e.coli based biopharmaceutical production processes3.3 Capability to work in a team and ability to handle demonstrate a good team spirit3.4 Strong interpersonal skills are required with the ability to work cross-functionally with internal and external customers