Master or PhD degree with major in Chemistry, Biochemistry, Molecular Biology, Biological Engineering, or related field, minimum 2 years of relevant industry experience for Ph.D., minimum 5 years for Master’s.
Knowledge and expertise in some the following fields: Chromatographic and spectral techniques related to HPLC, UPLC, GC, CE, icIEF etc.;
In-depth knowledge in FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines.
Good
communication skills in English and Chinese, fluent in writing and reading in both languages. Critical thinking, scientific reasoning and problem solving skills.
JOB RESPONSIBILITY:
Manage a group of analysts and project activities.
Provide high quality, on-time testing in compliance with regulatory requirements to support on-going QC projects.
Write and review GMP and technical documents, such as SOP, analytical method, method qualification/validation protocols/reports etc.,
Serve as technical leader to solve technical challenges and support laboratory investigations and deviations.
Communicate with internal/external partners or clients to ensure timely completion of assigned word.