CMC Director

面议

杭州市博士及以上

刷新时间：2023-05-19

职位描述

Major responsibilities:

1. Serve as the Senior CMC leader for company pipelines.
2. Set strategies and lead the executions of CMC development of company projects.
3. Responsible for all CMC related activities including technology transfer, pilot amplification, development planning, management of the entire process of CMC development, and alignment with the overall project plan.
4. Provide technical leadership at different stages of process development of macromolecular projects, including initial process establishment, optimization, scale-up, process change, process validation, technology transfer, etc.
5. Maintain effective communication with internal and external stakeholders.
6. Monitor and control the CMC process within budget, and timeline.
7. Work closely with CRO/CMO and lead relevant project management.
8. Lead in reviewing of all CMO documents from protocols to batch records and reports, to ensure the scientific logic, integrity, traceability of content.
9. Work with Regulatory Affairs to ensure the timely delivery of CMC submission documents.
10. Complete other related tasks assigned by the senior management team.

Qualification：

1. PhD. in life science disciplines and with 7~10 years of working experience in the pharmaceutical/ biotech industry.
2. 7+ years of technical experience in one or more areas of Biologics CMC development and had led a team to successfully complete at least one CMC project focusing on DRUG SUBSTANCE.
3. Proficient in both upstream and downstream process development including establishment of analytical methods and phase-appropriate quality control under GMP and formulation development of macromolecular drugs.
4. Experience with clinical-stage CMC development including process robustness study (QbD) is a plus.
5. Demonstrated problem solving skills including anticipate/identify problems and takes appropriate action.
6. Familiar with the latest regulations and rules of FDA, NMPA, EMA. Strong knowledge of Chinese CMC regulations and guidelines including NDA and IND filing requirements as well as ICH guidelines. Strong working knowledge of GMP.
7. Experience with CMC technical content for regulatory submission is preferred.
8. Good organization and coordination skills and must be a good team player.
9. Excellent communication skill on both oral and written, both in Chinese and English.
10. Global pharma experience is a plus.

其他要求

招聘人数：1人
汇报对象：老板
语言要求：英语
职能类别：CMC

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。