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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.
Job Responsibility:
Resource Planning, Hiring, Training and Career Development and talent retain
Department Strategic Planning, formulating Key Performance Indicators & Action Plans
Lead AST team to lead or participate activities listed as below
Lead 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
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
Hire and train the right team: enhance project management and communication skills of QC project management team
Operation excellence: continuously improve and optimized QC project management workflow
Risk management: oversight all project activities in QC, identify and analyze problems, create innovative solutions, and make informed decisions to facilitate project success
Requirements:
Master or Ph.D in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, Statistics or related field
8+ years of bio-pharmaceutical industry experience, including 4-5 years team management experiences
Critical thinking, scientific reasoning and problem-solving skills
Good at technical writing in English and familiar with statistical analysis model
Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas
Strong communication skills in English and Chinese, fluent in speaking, writing and reading in both languages