理化分析岗位职责

熟练使用高效液相色谱仪，毛细管电泳仪，质谱仪进行检测，熟悉QC各项理化检测分析方法包含HPLC/UPLC, CE-SDS, iCIEF, UV，MS等。
根据生产计划完成中间过程样品，放行，稳定性检测，确保日常检测工作满足GMP要求，并对日常工作中遇到的问题及时解决
参与分析方法转移/确认/验证
起草分析方法文件等
参与各类质量事件如实验室事件，调查，偏差，OOS/OOT等
参与组内公共事务，如文件归档，试剂耗材采购/管理，5S，设备定期维护等
日常按时完成被安排的任务
需要具备的能力：有生物大分子相关QC理化检测经验，熟练使用高效液相色谱仪，毛细管电泳仪，质谱仪进行检测，
熟悉QC各项理化检测分析方法包含HPLC/UPLC, CE-SDS, iCIEF, UV，MS testing等。
熟悉中国药典，USP, EP，ICH等。具有良好的沟通能力，具备解决复杂问题的能力特别是检测过程中遇到异常图谱，异常数据，具备同时处理多种事务的能力。

Job Summary
The QC Product Testing Scientist will be part of various technical projects/activities in the QC Product Testing group of WuXi Biologics. Scientist will be involved in commissioning,qualification, validation routine testing aligned with project timelines. As part of the project, the role will evolve based on project timelines, may require candidates to carry out additional job functions not described in the job description but associated with the role.
Essential Duties Responsibilities
Perform analytical method transfer, verification, validation routine analysis using various analytical techniques; including but not limited to HPLC (Size Exclusion, Ion Exchange, Reverse Phase, Hydrophobic Interaction etc), IC, CE, cIEF UV, RT PCR, ELISA, Westen Blot, SDS-PAGE.
Support activities including general lab readiness, audit readiness, laboratory equipment qualification, routine calibration maintenance.
Identify prepare required GMP documents such as SOPs, protocols, methods reports.
Drive the establishment of required inventory fteam develop a system fstock control of laboratory consumables reagents.
Foster Operation Excellence continuous improvement environment; including implementing Lean tools (5S, Kanban Kaizen).
Maintaining high Quality, Compliance Safety system in a GMP Laboratory.
Participate in various Lab deviation investigation process such as OOS, OOT atypical results, including the implementation of CAPAs change control.
General laboratory support such as housekeeping, training support.
Consistently delivering monitoring specific Lab Key Performance Indicators.
Experience
Experience working in a Quality Control Lab relevant GMP environment.
Previous experience from Pharmaceutical/Biopharmaceutical using Chemistry analytical techniques; Liquid/Ion Chromatography, Electrophoresis Spectroscopy.
Experience with Empower LIMS related system is desirable.
Experience with Microsoft Word, Excel, PowerPoint is required.
Qualifications
University degree with 2 years of working experience Master‘s degree in related science/quality discipline required.
Behavioural Competencies
Ability to work in a team environment independently.
Excellent interpersonal, verbal, written communication skills
Comfortable in a fast-paced working environment able to adjust workload based upon changing priorities.
Ability to think critically demonstrate troubleshooting problem-solving skills.
Flexible approach to work a positive attitude will be a good fit within the team dynamic.
Engage cross functionally in conjunction with a site-based team.
Autonomous a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures policies, regulatory standards, our customers’ expectations.

岗位职责：
1、负责HPLC方法的开发，解决新分子可能遇到的开发难题，尤其针对HIC、Freedrug等方法，撰写对应的方法开发报告及验证方案；
2、遵循实验室各项规范，开展相关实验操作，保证研究工作的规范、真实和数据完整性；
3、参与项目管理，撰写相关汇报ppt，为研发部门及客户解读分析数据，对数据的科学性和准确性进行把控；
4、负责对新员工进行技能培训，保证顺利上岗，撰写相关培训讲义并进行培训；
5、对部门内部的平台方法优化、5s管理、仪器设备维护、国产化或低成本试剂替代等提出合理化建议；
6、了解行业发展的*新动态，撰写相关技术的推广文章。
任职资格
1、硕士1年或以上生物制药行业分析工作经验，有海外留学经验者优先；
2、有单抗、重组蛋白、ADC、双抗、纳米单抗等行业分析经验优先；
3、良好的学习能力、团队合作精神、沟通能力 ，抗压能力强；
4、具备一定的团队管理经验；
5、对CHP、USP、EP等相关法规的应用熟悉。