- Technical Responsibilities 1.1 Execute and operate upstream manufacturing batch activities 1.2 Operate process equipment like fermenter, centrifuge, homogenizer, mixers, autoclave, etc. 1.3 Manage vial thaw, cell counting and other seed expansion activities 1.4 Manage media preparation and filtration activities 1.5 Maintaining Quality Management Systems related documentation like - deviations, change controls, risk assessment documents etc. 1.6 Monitoring of batch performance and data 1.7 Hands-on experience with SS fermenters 1.8 Experience in the equipment qualification and validations 1.9 Proper documentation of batches as per SOP and written procedures
2.0 GMP compliance
2.1 Apply Good Manufacturing Principles in all areas of responsibility
2.2 Follow environment, health, and safety (EHS) requirements in the workplace
2.3 Ensuring compliance to cGMP in area as defined by SOPs
3.0 Skills Required
3.1 Working in a cGMP environment.
3.2 Experience in e.coli based biopharmaceutical production processes
3.3 Capability to work in a team and ability to handle demonstrate a good team spirit
3.4 Strong interpersonal skills are required with the ability to work cross-functionally with internal and external customers
