Lead tech transfer execution by organizing the team, managing project plans with milestones, and driving risk and crisis management to ensure on-time, high-quality transfer
Job Summary
Lead tech transfer execution by organizing the team, managing project plans with milestones, and driving risk and crisis management to ensure on-time, high-quality transfer.
Design and execute comparability studies and process investigations to improve robustness, yield, and manufacturability.
Support compliance and regulatory activities including GMP audits, on-site inspections, and regulatory filings.
Matching Summary
Lead tech transfer execution by organizing the team, managing project plans with milestones, and driving risk and crisis management to ensure on-time, high-quality transfer.
Skills & Requirements
Must-have
Tech transfer management
Advanced statistical analysis
Process validation execution
Manufacturing troubleshooting
GMP compliance
Comparability study design
Nice-to-have
Experience with NDA/BLA submissions
Overseas work experience
Strong written and oral English
Inclusive and diverse team culture
Key Requirements
Master’s degree in biological or pharmaceutical discipline
More than 8 years’ experience in MSAT or process development
Graduates from 211/985 Project universities preferred
Experience with cell and gene therapy industry submissions preferred