[江苏其它]迪哲（江苏）医药有限公司

职位：药物分析助理科学家
发布时间：2024-10-15
工作地点：其它
信息来源：复旦大学
职位类型：兼职
专业标签：药学
职位描述
迪哲（江苏）医药有限公司
发布时间：2024-10-15 09:06:29
招聘职位：药物分析助理科学家
职位信息：
职位类别：科学研究人员
学历要求：硕士及以上
招聘人数：5人
工资：200
联系邮箱：

联系电话：02161095736
联系手机：18818206057
工作地点：亮景路199号
职位描述：
职位描述：


Responsibility: ?Assist Scientist Sr. Scientist to lead analytical activities for drug substance drug product development of assigned projects to ensure their completion with high quality and on time. ?Perform development, validation, verification, and transfer of analytical methods of R&D and commercial phase for the analysis of raw material, in-process control samples, intermediates, final products, and cleaning verification samples. ?Lead stability studies, including all components of investigational and commercial medicinal products. ?Perform and review analysis of raw material, in-process control samples, intermediates, final products, and cleaning verification samples. ?Write review technical reports and CMC analytical section regulatory submission and response. ?Contribute to the establishment of department SOP and work instructions. ?Ensure all lab processes are adhering to relevant regulatory GMPs and company policies and SOPs. ?Supervise and manage the quality control activities and laboratory processes of the contract manufacturer/contract laboratory, and implement the review approval of documents/records to ensure their compliance with GMP specifications and data reliability. ?Work collaboratively with CRO/CDMO, QA, other CMC functions to drive continuous improvement. ?Monitor ARD KPIs and drive improvements. Requirement: ?Effectiveal and written communication skills in both English and Chinese and ability to appropriately communicate information to cross functional stakeholders and suppliers. ?Knowledge of GMP, ICH, and safety guidelines. ?Solid knowledge of all laboratory equipment (e.g., HPLC, GC, KF, Titrator). ?Strong problem-solving skills. ?Knowledge of statistical assessments of data. ?Proficiency in Microsoft Office Suite. ?Experience of project management and writing laboratory SOPs. ?Willing to travel approximately 5 - 10%.



单位详情：
迪哲医药（股票代码：688192）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了六款具备全球竞争力的产品管线，其中两大处于全球关键性临床试验阶段的领先产品，均已在中国获批上市。