Quality Control Lead

5 days ago


Singapore BIOSYNGEN PTE. LTD. Full time

**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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