Director of CMC（大分子方向）

50-0万元/年

南京市硕士及以上

刷新时间：2018-03-27

职位描述

Responsibility
1) Create and implement the CMC development strategy through early development to production launch, and to post life cycle management.
2) Create and execute the CMC budget and timelines.
3) Oversee scientific, planning and execution of all aspects of biologic product CMC development, including but not limited to process development of drug substance and product, analytical method development,and establishment of spec., and manufacture of clinical trial material etc.
4) Manage project internal CMC team, CMO and CRO,and communicate with project team and management team effectively to ensure meet development timeline within budget.
5)Ensure the delivery of clinical and launch drug supplies in accordance with development plans.
6) Author, revise and review CMC regulatory documents and responses
7) Ensure compliance of current GMP’s , regulation and guidance of FDA and CFDA of all CMC related aspects.
8) Demonstrate behaviors consistent with the current Leadership Imperatives and cooperate culture.
9)Mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration with line management
Qualifications
1) A Bachelor's degree in life science or related field with at least 8 years of experience in pharmaceutical, biotechnology or a related industry OR a Master's degree in life science or related field with at least 5 years of experience in pharmaceutical, biotechnology or a related industry OR a Ph.D. with at least 3 years experience in pharmaceutical, biotechnology or a related industry is required
2) Large Molecule CMC experience is required; Experience in setting development and regulatory strategies for products in development is preferred.
3) Demonstrated capability to manage multiple projects．
4) Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines．
5) Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment.
Location
US (east coast) and China

其他要求

招聘人数：1人
所属部门：CMC部
汇报对象：总经理
下属人数：5人
语言要求：普通话、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。