Job responsibility 工作职责61 Technical responsibility技术系职责61Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method.熟悉生物大分子HPLC/CE 方法的建立与优化.61 Familiar with HPLC/CE method validation in release inspection and write method validation report after method validation. 熟悉放行检查中HPLC/CE方法的验证，并在方法验证完撰写方法验证报告；61 Responsible for characterization of Free thiol and CD in product quality consistency evaluation负责产品质量一致性评价中自由巯基、CD等表征工作；61 Responsible for IND registration application product inspection and write pharmaceutical data.负责IND注册申报产品的检验及药学资料的撰写。Safety and environment 现场安全和环境合规61 Take part in the site safety through promotion of safe workplace and personal action. 通过宣传安全的工作场所和个人行为，参与到工作现场的安全中。61 Adhere to the Company’s safety and environmental protection procedures. 遵守公司的安全环保程序。Quality Assurance 质量要求61 Take part in Quality Management System documentation covering the development and tech transfer processes and procedures.参与整个开发和技术转移过程和程序的质量管理体系。61 Comply with the Company Quality Management System for development activities. 遵守公司制定的研发质量管理体系。General 常规要求61 Take responsibility of the general operation and maintenance of the protein analytical laboratory facilities.负责蛋白质分析实验室设施的一般操作和维护;61 Other reasonably duties as requested by Company Senior Management from time to time.完成领导提出的其他任务Qualifications
任职资格61 Major in Pharmaceutical analysis or related field. 药物分析相关专业.61 Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.相关专业的本科或硕士学历。Essential Experience必要经验61 BS degree with a minimum of 2~4 years and MS degree with a minimum of 1~3 years of large Biomolecule analysis experience.本科2~4年，硕士1~3年相关生物大分子分析经验61 Expert knowledge in protein biochemistry related to protein purification and characterization of MAbs and recombinant proteins.有单克隆抗体和重组蛋白分析和表征的蛋白质生物化学方面的专业知识。61 Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing.熟悉文献检索及相关信息检查，熟悉IND备案；61 Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook); 熟练使用Microsoft Office办公软件 (Word、Excel、Powerpoint、Project、Outlook)Preferred Experience优先考虑61 Project management of CMC filing for US, EU, and China IND/BLA.具有美国、欧盟和中国项目申报方面的管理经验。61 Biophysical methods for protein characterization.熟悉蛋白表征的分析方法。61 Formal root-cause analysis training. 严谨的问题分析能力61 Advanced computer system skills including Unicorn, Empower, and DoE and statistical analysis.高级的计算机系统能力，包括Unicorn, Empower, and DoE和统计学分析。
职能类别：药物分析研究员 关键字：hplcce生物大分子