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.
· 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.