[无锡-新吴区]迪哲（江苏）医药股份有限公司

职位：药物分析助理科学家（上海）
发布时间：2024-11-15
工作地点：其它
信息来源：前程无忧(51JOB)
职位类型：全职
专业标签：药学
职位描述
专业1:药学
专业2:药物分析
职能类别:药物分析研究员
This role is to perform analytical activities of R&D and commercial phase for drug substances or drug products including planning and performing analytical method development, validation and analysis for raw material, in-process control samples, intermediates, and final products, as well as writing or reviewing analytical documents under supervision of Sr. Scientist or Scientist.
在科学家或资深科学家的指导下，该角色负责研发和商业化阶段原料药或制剂有关的分析活动，包括规划和执行分析方法开发和验证，原料、中控样品、中间体和最终产品分析，以及撰写或审核分析文件。
Responsibility:
? Assist Scientist or Sr. Scientist to lead analytical activities for drug substance or drug product development of assigned projects to ensure their completion with high quality and on time.
帮助科学家或资深科学家负责项目的原料药或制剂研发有关的分析活动, 确保高质量、按时完成分析工作。
? 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.
执行原料、中控样品、中间体、最终产品以及清洁验证样品研发和商业化阶段所用分析方法的开发、验证、确认和转移。
? Lead stability studies, including all components of investigational and commercial medicinal products.
负责稳定性研究，包括临床试验用药品和已上市商业化产品。
? Perform and review analysis of raw material, in-process control samples, intermediates, final products, and cleaning verification samples.
执行和审核原料、中控样品、中间体、最终产品和清洁验证样品的分析工作。
? Write or review technical reports and CMC analytical section regulatory submission and response.
撰写或审核技术报告和CMC分析部分注册资料和回复。
? Contribute to the establishment of department SOP and work instructions.
协助制订部门SOP和工作指南。
? Ensure all lab processes are adhering to relevant regulatory GMPs and company policies and SOPs.
确保所有实验室流程符合相关GMP法规、公司政策和SOP。
? Supervise and manage the quality control activities and laboratory processes of the contract manufacturer/contract laboratory, and implement the review or approval of documents/records to ensure their compliance with GMP specifications and data reliability.
监督管理合同生产方/合同实验室的质量控制活动和实验室流程，执行文件/记录的审核或批准，确保其符合GMP规范和数据可靠性。
? Work collaboratively with CRO/CDMO, QA, other CMC functions to drive continuous improvement.
持续改进与CRO/CDMO，QA和其他CMC部门的合作。
? Monitor ARD KPIs and drive improvements.
关注并推动改进ARD绩效指标

Requirement:
? Effective oral and written communication skills in both English and Chinese and ability to appropriately communicate information to cross functional stakeholders and suppliers.
有效的中英文口头和书面沟通能力，能够与跨部门负责人和供应商进行合适的沟通。
? Knowledge of GMP, ICH, and safety guidelines.
熟悉GMP, ICH和安全指南。
? Solid knowledge of all laboratory equipment (e.g., HPLC, GC, KF, Titrator).
掌握所有实验室设备 （如HPLC, GC, KF, 滴定仪）。
? Strong problem-solving skills.
较强的解决问题的能力。
? Knowledge of statistical assessments of data.
熟悉数据统计分析知识。
? Proficiency in Microsoft Office Suite.
熟练使用微软Office办公软件。
? Experience of project management and writing laboratory SOPs.
有项目管理和撰写实验室SOP的经验。
? Willing to travel approximately 5 - 10%.
愿意出差大约5 - 10%。 公司简要介绍：
公司名称:迪哲（江苏）医药股份有限公司
公司类型:外资（欧美）
公司介绍: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，公司已建立了五款具备全球竞争力的产品管线，两大领先产品处于全球关键性临床试验阶段，其中一款已获批上市。

Dizal Pharmaceutical Co., Ltd (Ticker: 688192 ) is a commercial stage biopharmaceutical company. At Dizal we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. Building on our extensive expertise in translational science and molecular design, we have established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already approved.