Cell Culture Specialist
7 days ago
Production Scientist Role
As a Production Scientist, you will play a crucial role in ensuring the production of high-quality cell culture products. This involves performing well-defined procedures in GMP manufacturing settings and Research and Development environments, adhering to strict quality control standards.
- Perform routine procedures in GMP manufacturing settings and R&D environments to maintain product quality and integrity.
- Conduct equipment monitoring and basic housekeeping tasks to maintain a clean and organized workspace, promoting a safe working environment.
- Carry out laboratory testing, including pH, conductivity, cell density, viability, Mycoplasma, PCR tests, and Flow cytometry, providing critical data for process improvements.
- Execute routine clean room sanitization tasks to uphold Clean room ISO standards, maintaining a contamination-free environment.
- Demonstrate aseptic technique when handling products and materials, participating in Aseptic process simulations to ensure competence.
- Multi-task exposure in cGMP manufacturing and Validation tasks, as well as Research and Development trail runs, developing skills in multiple areas.
- Support Protocol preparation, execution, and summary reports for Validation runs and development studies, providing valuable insights.
- Achieve full competency in performing assigned operations, ensuring compliance with regulatory requirements.
- Become a technical process expert by understanding critical process/operational parameters and target/acceptable ranges, driving process improvements.
- Utilize Standard Operating Procedures (SOPs), logbooks, and Batch Manufacturing Records (BMR's) effectively and competently, streamlining processes.
- Participate in internal and external audits, ensuring adherence to industry standards and regulations.
- Support Change control, Deviations, investigations, and CAPA initiation and closure, resolving issues efficiently.
- Assist in process development, creating scalable processes with improved product yield and reduced manufacturing system costs, driving business growth.
Key Skills and Qualifications
- Knowledge of aseptic technique for thaw and subculture stages using T flasks and Cell factories, ensuring product quality.
- Understanding of Cell culture, trypsinization, Centrifugation, and resuspension, providing critical knowledge for process improvements.
- Experience with Benchtop setup for Cell culture supernatant Clarification, supporting research and development.
- Knowledge of small-scale column chromatography techniques, tangential flow filtration techniques, Final Filling techniques in BSC and Isolators, driving process efficiency.
- Ability to handle single-use chromatography columns and tangential flow filtration skids, enhancing productivity.
Requirements
- Degree/Diploma in a related Science/Engineering discipline, providing a solid foundation for the role.
- 1-3 years relevant work experience in a similar manufacturing industry or cleanroom environment, demonstrating expertise.
- Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage, showcasing adaptability.
- Knowledge of cGMP applications, ensuring compliance with industry standards.
- Positive team-oriented attitude, fostering collaboration and teamwork.
- Strong communication and interpersonal skills, facilitating effective communication and relationships.
- Flexibility to adjust schedule to support GMP manufacturing and R&D trial Runs, demonstrating adaptability.
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