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.
