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.
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