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Physicochemical Analysis(副总监)
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60-70万 上海、无... 研究生 5-8年 招聘 2 人 预计佣金 93.4K 1天前刷新/一周前发布
SSS
JD基本信息
岗位职责
Responsibilities: • Lead an analytical physicochemical function team enabling IND and BLA filing for multiple CMC projects. • Support development and execution of the department’s mid/long-term technical strategy and annual work plans. • Lead the analytical activities in CMC projects as function leader or function sponsor of Analytical Sciences. Coordinate with internal experts and other CMC functional areas to design tailored studies to meet regulatory standards and project objectives. Closely monitor the project with continuous scientific and technical support. Proactively identify potential issues and provide constructive suggestions timely. Prepare the analytical sections of filing dossiers to support regulatory submission including INDs and BLAs. • Engage directly with domestic and international clients to convey analytical progress and resolve project-related technical challenges. • Oversee analytical method development, validation/verification, method transfer, stability programs, release testing and troubleshooting to ensure on-time, high-quality delivery. • Cultivate talent and foster continuous improvements in physicochemical analysis and project management practices. • Laboratory management, including compliance, EHS, 5S, and instrumentation.
任职要求
Qualifications: 1. Ph.D. or M.S. in biochemistry, protein science, analytical chemistry, or related discipline, with specialized training in HPLC/UPLC, CE/iCIEF, or MS techniques. 2. 5–10+ years in pharmaceutical analytical science or related fields, including at least 3 years in team or project management. 3. Proficient understanding of HPLC/CE/MS principles and technologies, and hands-on experience in operation, maintenance and troubleshooting of HPLC/CE/MS. 4. Demonstrated expertise in physicochemical analysis of proteins and bioconjugates. 5. Working experience as function leader or function sponsor for CMC projects. 6. Strong team player with exceptional interpersonal, communication and presentation abilities, both written and verbal. 7. Proven track record as a proactive, independent researcher with advanced problem-solving skills and multitasking abilities. 8. Proficient in English communication, including reading, listening, writing, and speaking.
所属行业:
生物制药
职能分类:
分析方法开发
工作城市:
无锡,招聘1人,详细地址:无锡新吴区上海,招聘1人,详细地址:上海外高桥
职位要求
学历要求:
研究生
工作年限:
5-8年
技能/证书:
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薪资福利
年薪范围:
60-70万*12薪
薪资福利:
年终奖金、股权
团队架构
所属部门:
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下属人数:
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职级职称:
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面试信息
面试轮次:
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面试流程:
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视频面试:
不可以接受