Lead tech transfer execution by organizing the team, managing project plans with clear 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 clear milestones, and driving risk and crisis management to ensure on-time, high-quality transfer.
Design and execute comparability studies and perform advanced data analytics to generate insights and inform decisions across development and manufacturing.
Support compliance and regulatory activities including GMP audits, on-site inspections, and regulatory filings as required.
Matching Summary
Lead tech transfer execution by organizing the team, managing project plans with clear milestones, and driving risk and crisis management to ensure on-time, high-quality transfer.
Skills & Requirements
Must-have
Tech transfer project management
Data integrity and compliance
Comparability study design and execution
Advanced statistical data analysis
Process validation strategy and execution
Manufacturing troubleshooting and resolution
GMP compliance and regulatory support
Nice-to-have
Experience with NDA/BLA submissions
Overseas work experience
Strong written and oral English skills
Experience in MSAT or process development
Knowledge of QbD and related regulations
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