Qifeng Bao Email and Phone Number

• Technical lifecycle management of Secondary production including formulation, filling , lyophilization and packaging for Influenza virus splitting vaccine and Meningitis vaccine through QbD, MRRB and CPV to ensure the process robustness and seek for potential process improvement chances by science-based study and statistical analysis.• Routine in-process data trending with 6 sigma management tool to indentify process risks and take actions proactively. Leading the critical deviation investigation and process related change control.• Project manager of local thiomersal-free influenza virus inactivated, splitting vaccine variation. Leading Cross-function project team to prepare the 18 months stability data, Change dossier and quality standard for CDE review. Local thiomersal-free influenza virus vaccine was finally approved in Sep, 2017.

 FMEA and HACCP risk assessment for filling process of local Meningitis and Rabies vaccine product Leading critical process-related deviation investigation and study.TLP (Technology leadership program) Pre-CTA dossier draft for local newly developed Flu vaccine and test method validation for Flu vaccine Product lifecycle management of local Flu product primary product (from harvest to bulk). Process monitoring, optimization and deviation investigation for Flu primary product.

Rotation in Technical development department, responsible for :1. test method validation for newly developed Flu product .2. Pre-CTA dossier preparation.