Key responsibilities:Learn and perform well-defined procedures in GMP manufacturing setting and Research and Development SettingsPerform equipment mon.....
Key responsibilities:
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).
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
Purification (Downstream)
Skill and knowledge of small-scale column chromatography techniques, tangential flow filtration techniques, final filling techniques in BSC and isolators
Knowledge in handling single use chromatography columns and tangential flow filtration skids.
Key requirements:
Degree/Diploma in a related Science/Engineering discipline
1 to 3 years relevant work experience in a similar manufacturing industry or cleanroom environment
Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage.
Knowledge of cGMP applications
Positive team-oriented attitude
Strong communication and interpersonal skills
Flexible to adjust the schedule to support GMP manufacturing and R&D trial Runs.
