锦鲤求职岗位描述
Responsibilities：1.Promptly and properly document tests and results per Good Documentation Practice (GDP) requirement.2.Perform physicochemical 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.3.Write and revise AMP, method transfer/qualification/validation protocol and report.4.Write SOP and other technical documents.5.Perform laboratory investigation following relevant SOP.6.Perform method optimization and troubleshooting when necessary and lead technical discussion.7.Proactively search for opportunities to improve efficiency, quality and achieve technical excellence.8.Review test records including lab notebook, worksheet, electronic data and audit trail.9.Perform deviation investigation, change control, and CAPA following relevant SOP.10.Work as QC Function Leader to coordinate project related activities in QCRequirements：1.Education background in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or others related field. At least two years' relevant work experiences for Master and five years' work experience for Bachelor degree holder.2.Knowledge in some the following fields: Chromatographic and spectral techniques related to HPLC, UPLC, GC, CE, icIEF, IR and Raman, etc.;3.Knowledge in FDA/EMA/CFDA cGMP regulations, Pharmacopoeias, and ICH guidelines.4.Good communication skills in English and Chinese.5.Critical thinking, scientific reasoning and problem solving skills6.Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.