CELL CULTURE (UPSTREAM)

• Skill and knowledge of aseptic technique for thaw and subculture stages using T flasks and Cell factories, etc.
• Knowledge of handling Cell culture, trypsinization, Centrifugation and resuspension. Cell Culture Passaging from flask / Cell factories.
• Benchtop set up for Cell culture supernatant Clarification

• Learn and perform well-defined procedures in GMP manufacturing setting and Research and Development Settings
• Perform equipment monitoring and basic housekeeping
• Perform laboratory testing (e.g. pH/ conductivity/Cell density / Viability, Mycoplasma, PCR test and Flow cytometry … etc.)
• Perform routine Clean room sanitization tasks to maintain the Clean room ISO standards
• Demonstrate aseptic technique in the handling of product/ materials and requirement to participate in Aseptic process Simulations.
• Multi-task exposure on cGMP manufacturing and Validation task and Research and Development trail runs.
• Support for Protocol preparation, Execution, and summary report for Validation run and development studies
• Attain full competency in the performance of all operations as assigned.
• Become a technical process expert by exhibiting basic understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
• Use Standard Operating Procedures (SOPs), logbooks & Batch Manufacturing Records (BMR’s) effectively & competently
• Taking part in the internal and external audit.
• Support for Change control, Deviations, investigations and CAPA initiation and closure
• Assist in process development, in creating scalable processes with improved product yield and reduced manufacturing systems costs
• Support Facilities Engineering team to perform maintenance, troubleshooting, calibration, and repair instrumentation (where applicable).