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 Assusrance 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 immune cell products, previous quality test experience of CAR-T/TCR-T/NK cell products is highly desired.
- Experience in FDA IND filing.
- Familiar with immune cell manufacturing, 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.
SKILL REQUIREMENTS:
- Experience in qPCR, flow cytometry and ELISA would be preferred.
- Able to write/read Chinese will have an advantage.
