Job Responsibilities/岗位职责
? Participate in purification production, especially in chromatography, including AC, AEX, CEX, column packing & unpacking, and on-duty.
参与纯化生产,特别是层析,包括亲和层析、阴离子交换层析、阳离子交换层析、层析柱装填与卸载、值班。
?Participate in purification production, especially in filtration, including depth-filtration, virus-filtration, DS final filtration, and on-duty.
参与纯化生产,特别是过滤,包括深层过滤、去病毒过滤、原液最终过滤和值班。
? Participate in the daily activities of the purification Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility;?
参与纯化组的日常生产活动,应用适当的个人防护用品去完成在厂房内的所有工作;
? Participate in the evaluation of new technology, new production process and new production technology; ?
参与评估新工艺、新生产流程和新生产技术;
? Escalate process issues as necessary to ensure resolution;?
根据需要上报工艺中的问题并保证解决问题;
? Author MGF-DSP GMP documents, ensure GMP training requirements are complete and current;?
起草生产部纯化组的GMP文件,确保完成和更新GMP培训要求;
? Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements;?
保证严格根据所有的SOPs和cGMP/质量要求来操作;
? Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request;?
确保安全的方式去执行所有的工作,操作符合EHS要求,并符合各个服务请求的标准;
? Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene;?
清洁和维护GMP厂房和生产设备,保持环境和个人卫生;
? Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams;?
根据需要参与公司的内部审计计划;能够担任跨职能团队的部门代表;
? Other work arranged by superior leaders.?
上级领导安排的其他工作。
Job Requirements/岗位要求
? College degree or above, major in chemistry, chemical engineering, life sciences or related fields; ?
大专及以上学历,化学、化学工程、生命科学或者相关专业;
? Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs;?
对于生物制药技术,特别是单克隆抗体或者重组融合蛋白药物的工艺流程有一定了解;
? Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills;?
能够撰写详细的报告和总结,并展示注重细节的文档技能;
? Communicate effectively and work professionally in a team environment;?
善于在团队中进行有效的沟通和专业的工作;
? Familiarity of computer-based systems;?
熟悉计算机系统;
? Must be flexible to work on any shift (day, night, weekend) and able to work prolong durations on your feet;?
必须灵活的参与任何轮班(白班,晚班,周末),并能够长时间站立工作;
? Oral and written communication skills in Chinese and English (Read, Write, Verbal). ?
良好的中英文读写和沟通能力。