Quality Control Lead
1 month ago
Our client is a cell therapy company with a focus on solid tumors and immunology diseases. They're currently expanding and looking for a Quality Control Lead to join their team in Singapore.
Responsibilities:
- 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
Requirements:
- Bachelor & more advanced degree in cell biology /biomedical sciences or in a similar medical technology related field
- 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
- Able to read/write Chinese is an advantage
- Candidates with less experience will be considered as QC Associate
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