Quality Control Lead (Candidates with less experience will be considered as QC Associate)

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