The role involves participating in daily QC cell group inspections and management to ensure compliance with domestic and international laws and internal quality requirements
Job Summary
The role involves participating in daily QC cell group inspections and management to ensure compliance with domestic and international laws and internal quality requirements.
The position requires organizing and executing complex instrument SOP drafting, method validation, and sample release testing including materials like lentiviral vectors and CAR-T samples.
Candidates must adapt to a fast-paced, low-tolerance environment with high-intensity inspection tasks and be capable of shift work or overtime.
Matching Summary
The role involves participating in daily QC cell group inspections and management to ensure compliance with domestic and international laws and internal quality requirements.
Skills & Requirements
Must-have
QC cell group inspection and management
GMP environment experience
Flow cytometry operation and analysis
Cell culture techniques
Analysis method validation
Handling OOS and deviation quality events
Ability to work under high pressure and fast pace
Nice-to-have
Experience with CAR-T cell culture and testing
English writing skills for SOPs and reports
Experience with BD Canto or Lyric flow cytometers
T cell and HeLa cell line culture experience
Stable study protocol drafting and implementation
Team collaboration and quality system improvement
Key Requirements
Bachelor degree or above in pharmacy, biology, basic medicine, or laboratory medicine
3+ years QC experience in biopharmaceutical industry
At least 2 years working in GMP environment
CET-6 English proficiency with strong writing skills