As a problem solver and technical leader, lead WX site QC AST team or Global QC AST team to continuously improve QC data quality and operation efficiency, including but not limited to:
1. Continuously to evaluate and optimized analytical method to ensure method performance can meet its intent purpose.
2. Lead laboratory investigation, to ensure thorough investigation of root cause and related actions taken.
3. Lead method transfer from clients or between different XDC sites.
4. Lead method validation form PPQ projects.
5. Assess and introduce new technology to continuously improve QC operation efficiency and data quality.
1. Resource Planning, Hiring, Training and Career Development and talent retain.
2. Department Strategic Planning, formulating Key Performance Indicators & Action Plans
3. Lead AST team to lead or participate activities listed as below
√Lead P analytical method optimization and validation activities.
√ Draft and review technical documents such as methods, qualification/validation protocols and reports.
√Serve as technical leader to solve technical challenges and lead laboratory investigations.
√Communicate with internal/external partners or clients to ensure timely completion of method validation and smooth transfer of analytical methods.
√Do statistical analysis based on historical data for method performance or for lab investigation purpose.
√New technology introduction and QC testing capability improvement.
10+ years of biopharmaceutical industry experience for Master or 8+ for PhD.