StemiGen Therapeutics is a Singapore biotechnology start up with a focus in the manufacturing of mesenchymal stem cells for clinical applications for regenerative medicine to meet the needs of aging societies worldwide. The company is seeking three suitable candidates to join the Team:
Job Responsibilities:
- Support superior in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources.
- Support the design and development of quality procedures, processes, and standards to ensure alignment to quality policy and local regulatory guidelines.
- Provide technical assistance to production on quality and process improvements and perform troubleshooting when necessary.
- Responsible to write and/or update all relevant documentation for project activities.
- Support quality manager during internal and external audit.
- Conduct QC test for every batch of raw material, in-process and finished product.
- Execute the technical transfer and validation protocol for QC assays.
- Assist in the implementation of new assay methodologies and the associated instrumentation.
- Proper issuance and filing of documents in accordance with GxP documents.
- Perform equipment monitoring and basic housekeeping.
- Perform routine clean room sanitization task to maintain the cleanroom ISO standards.
- Identify and facilitate continuous improvements.
- Maintains inventory and submit purchase requests as needed.
- Any other tasks / projects assigned by supervisor.
Job Requirements:
- Degree in biomedical science/biotechnology or related discipline.
- 1 – 3 years working experience in QA/QC role or relevant work experience in similar manufacturing industry or cleanroom environment.
- Proven experience in cGMP, FDA regulations and ICH Guidelines regarding the manufacture of biological products.
- Good knowledge in quality assurance tools, concepts, and methodologies.
- Experience in writing and/or review of GxP documents to ensure good
documentation, data integrity, GxP and regulatory requirements are met.
- Experience in cell/gene therapy is preferred.
- Expertise in cell culture, flow cytometry and molecular biology.
- Self-initiated, able to work independently and in a team.
- Ability to communicate at all levels.