ADC 组长 /副总监/总监

面议

市辖区

刷新时间：2021-08-30

职位描述

（1人）：
1. Design the ADC GMP production processes suitable for the clinical manufacturing, including process development of linker payload, conjugation, purification, analytical validation.
2. Arrange production activities, including material flow, and inventory to achieve cost and quality targets and production schedules of the ADC.
3. Supervise and monitor the operation activity to ensure compliance of standards (e.g. EHS standards, GMP, quality standards, customers’ requirements).
4. Assist the department head to coordinate resources between the ADC development group and other functional groups to meet the project objectives and timelines.
5. Oversee the process scale-up and technology transfer between the ADC process (including linker payload) development team and manufacturing team.
6. Coach the group leads and staff on the process development and validation.
7. Prepare the technical reports on the process of ADC, process-related application materials and other documents in accordance with the submission to FDA/EMA/CDE.

任职要求：
1. MS with7+ years, or PhD with 3+ years of ADC process development and GMP production experience.
2. At least 2 years’ people management experience.
3. Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and ADC technology preferred.
4. Experience in linker payload and conjugation process of ADC cGMP production.
5. Skillful in oral and written English communication with the clients.
6. Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the ADC development, technical transfer, production and process validation.


ADC 组长 /副总监/总监（1人）：
1. 设计适合临床生产的ADC GMP生产工艺，包括linker payload的工艺开发、偶联、纯化、分析验证。
2. 安排生产活动，包括物料流和库存，以实现 ADC 的成本和质量目标以及生产计划。
3. 监督和监控运营活动以确保符合标准（例如 EHS 标准、GMP、质量标准、客户要求）。
4. 协助部门负责人协调ADC组与其他组之间的资源协调，以满足项目目标和时间表。
5. 监督ADC工艺（包括linker payload）开发团队和生产团队之间的工艺放大和技术转移。
6. 指导小组领导和员工进行流程开发和验证。
7、按照提交FDA/EMA/CDE的要求，准备ADC工艺技术报告、工艺相关申请材料等文件。
 
要求要求：
1. 硕士7年以上

其他要求

招聘人数：1人
职能类别：研发总监/研究院院长

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。