· Participate in analytical method optimization, transfer/validation activities, including strategy discussion and experiments execution.
· 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.
· Draft and review technical documents such as methods, transfer/validation protocols and reports.
· Update and review SOPs such as method validation and laboratory investigation based on the updated regulatory.
任职要求
· Master's degree or higher in Analytical Chemistry, Biochemistry, Molecular Biology, Biological Engineering, Statistics, or a related field.
· 1-2 years of experience in the bio-pharmaceutical industry for a PhD, and a minimum of 3 years for a Master's degree.
· Strong communication skills in English and Chinese; 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.