QC药典分析员*2

1. 01

   Education background in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or others related field.One or two year experience in (bio)pharmaceutical industry2.Knowledge in some the following fields:Chromatographic and spectraltechniques related to HPLC, UV, appearance, osmolality, pH, residual moisture, HIAC, etc. ;Knowledge in FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines)3.Good communication skills in English and Chinese.4.Critical thinking, scientific reasoning and problem solving skills5.Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.JOB RESPONSIBILITYPromptly and properly document tests and results per Good Documentation Practice (GDP)

.Perform GMP routine testing and method setup experiments of Antibody-Drug Conjugate (ADC) samples according to relevant Standard Operation Procedure (SOP), Analytical Method Procedure (AMP), protocols, test methods and cGMP requirements.Write and revise AMP, method transfer/qualification/validation protocol and report.Write SOP and other technical documentsPerform laboratory investigation following relevant SOP.Perform method optimization and troubleshooting when necessary and lead technical discussion.Proactively search for opportunities to improve efficiency, quality and achieve technical excellence.Review test records including lab notebook, worksheet, electronic data and audit trail.Work as QC Function Leader to coordinate project related activities in QC