Analytical Science and Technology & Project Leader

Job Summary:
As a team leader to ensure projects are delivered on-time with high quality and ensure methods implemented in QC are science and risk-based and suitable for the evaluation of the quality of drug substances and drug products.
Responsibilities:
As AST leader, he/she is responsible for:
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
1)Lead analytical method optimization and validation activities.
2)Draft and review technical documents such as methods, qualification/validation protocols and reports.
3)Serve as technical leader to solve technical challenges and lead laboratory investigations.
4)Communicate with internal/external partners or clients to ensure timely completion of method validation and smooth transfer of analytical methods.
5)Do statistical analysis based on historical data for method performance or for lab investigation purpose.
6)New technology introduction and QC testing capability improvement.
As FL leader, he/she is responsible for:
1.Resource Planning, Hiring, Training and Career Development and talent retain.
2.Department Strategic Planning, formulating Key Performance Indicators & Action Plans
3.Lead project team to work with QC testing team and other function department like analytical science team, manufacturing team and Quality assurance team to delivery all activities related to QC with high quality and meet project timeline
4.Hire and train the right team: enhance project management and communication skills of QC project management team
5.Operation excellence: continuously improve and optimized QC project management workflow.
6.Risk management: oversight all project activities in QC, identify and analyze problems, create innovative solutions, and make informed decisions to facilitate project success.
Requirements:
1.Mater or Ph.D in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, Statistics or related field.
2. 8+ years of bio-pharmaceutical industry experience, including 4-5 years team management experiences
3.Critical thinking, scientific reasoning and problem-solving skills.
4.Good at technical writing in English and familiar with statistical analysis model
5.Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas
6.Strong communication skills in English and Chinese, fluent in speaking, writing and reading in both languages.