Analytical Chemistry, (Sr./Principal) Investigator（北京or苏州）

面议

市辖区博士及以上

刷新时间：2022-09-21

职位描述

职位描述

Responsibilities:

Lead/participate analytical activities to support medicinal chemistry and preclinical development.

•Provide analytical and structural characterization data on newly synthesized compounds;

•Lead analytical team on the studies of the physicochemical properties and other pre-formulation assessments of selected compounds.

•Provide analytical support on preclinical tox studies.

Develop control strategies and methodologies for drug substances and drug products under a GxP environment.

•Ensure analytical activities are conducted in compliant with applicable GxP and EHS requirements.

•Ensure analytical data and related CMC documents fully meet data integrity requirements.

•Lead/participate analytical team to deliver all the project related milestones on time as agreed upon with global project teams.

•Lead/participate analytical team on developing and validating analytical test methods.

•Establish and set-up specifications for drug substances and drug products with justifications.

•Lead on stability study strategies, to support the retest dating of clinical supplies and final NDA filing in global markets.

•Author/review/approve experimental protocols, validation reports, test methods and technical memos/reports.

•Analyze data, evaluate results, and form conclusions.

•Ensure timely, accurate and compliant documentation.

任职条件

Qualification:

•PhD degree in Chemistry or other closely related disciplines with 0+ years relevant work experience in pharmaceutical industry.

•Knowledge with ICH guidelines, applicable law and regulations of major markets (China, US, EU, Japan, etc.), and other compendial requirements (USP, EP, ChP etc.)

•Good written and communication skills in English and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

•Possess thorough theoretical understanding of own scientific discipline.

其他要求

招聘人数：10人
职能类别：药物分析/药品检验

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。