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Role: Analytical Science and Technology Expert
Department: Quality Control (QC)
Job Summary
Lead lab investigations, SME of separation and biochemical assays, perform method performance and do statistical analysis, lead method transfer and method qualification/validation.
Responsibilities
- Participate in analytical method optimization, qualification/validation activities.
- Draft and review technical documents such as methods, qualification/validation protocols and reports.
- Serve as technical leader to solve technical challenges and support laboratory investigations.
- Communicate with internal/external partners or clients to ensure timely completion of method qualification/validation and smooth transfer of analytical methods.
- Do statistical analysis based on historical data for method performance or for lab investigation purpose.
Qualifications
- Bachelor's degree or higher in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, Statistics, or a related field.
- 1-2 years of experience in the biopharmaceutical industry for a Master's or PhD, and a minimum of 3 years for a Bachelor's degree.
- Strong communication skills in English and Chinese (as this role requires frequent internal collaboration with Chinese-speaking colleagues in HQ); fluent in speaking, writing, and reading in both languages. Critical thinking, scientific reasoning, and problem-solving skills. Familiar with statistical analysis.
- Proficient in technical writing in English and familiar with statistical analysis models and suitable ranges.
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