Quality Control Lead
3 days ago
**ROLE**: Responsible for GMP-compliant quality control tests of cell products**:
**JOB SCOPE**:
- Performing quality control tests for clinical materials (cell therapy products) according to GMP standards.
- Work with the Cell Manufacturing & Quality Assurance Team.
- Ensuring GMP compliance is maintained at all times.
Be accountable for the highest level of execution of regulatory strategies, and standards of quality compliance.
**EXPERIENCE REQUIREMENTS**:
- Experience in quality control tests of biologics or immune cell products, previous quality test experience of CAR-T/TCR-T/NK cell products is highly desired.
- Experience in regulatory filing with FDA/HSA is desired.
- Familiar with regular testing methods such as sterility/mycoplasma/endotoxin detection, flow cytometry analysis; Cytokine measurement assays; qPCR assays; etc.
- Self-motivated, good interpersonal skills.
Project management experiences.
**EDUCATIONAL REQUIREMENTS**:
- Bachelor & more advanced degree in cell biology /biomedical sciences or in a similar medical technology related field.
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