Job Summary

• Participate in the daily inspection and management of the QC cell group, including work arrangements and tracking, and establishment of the document system, to complete the inspection tasks of the group in a timely and efficient manner, and ensure that inspection activities comply with domestic and foreign laws and regulations and company internal quality requirements.
• Organize the implementation of QC cell group analysis method validation and the writing of validation reports to ensure the effectiveness of analysis methods.
• Organize personnel according to the plan to carry out release testing and quality research testing of materials, lentiviral vectors, and CAR-T samples, ensuring the authenticity and reliability of test data, and organizing the collection and organization of parameters during the inspection process.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor's degree or above
• 3+ years of QC experience in biopharmaceutical industry
• 2+ years of GMP environment experience
• English CET-6 or above
• Cell therapy related experience preferred
• Cell culture related theoretical knowledge
• Flow cytometry related theoretical knowledge
• CAR-T cell culture, efficacy, and flow related testing experience preferred
• Analysis method validation operation and report writing experience preferred
• Trend analysis of test results, OOS, deviation handling experience preferred

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