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Analytical Chemistry, Associate Director/Director(北京)

面议

北京市博士及以上

刷新时间:2022-09-26

职位描述

职位描述

Direct team on analytical activities to support medicinal chemistry and preclinical development.

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

•Direct 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.

•Direct and lead analytical team to deliver all the project related milestones on time as agreed upon with global project teams.

•Direct 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.

•Guide team to analyze data, evaluate results, and form conclusions.

•Ensure timely, accurate and compliant documentation.

Provide decisive leadership and operational expertise

•Work cross-functionally within the organization to help shape and meet product life-cycle timelines and support synthesis and formulation divisions.

•Ensure successful tech transfer between internal organizations and between ARD and TPL/CMO.

•Establishes and maintain an environment that assures the recruitment and retention of top talents, continued staff development and the recognition of high potential technical and managerial talents within areas of responsibility.

Demonstrate high proficiency across a wide range of relevant technologies. Maintain a high level of productivity in the lab and/or pilot plant

•Formulates conclusions and designs follow-on experiments based on multidisciplinary data.

•Ensures that high quality products are developed by applying strong scientific rationale, cutting-edge technologies, Quality by Design (QbD) principles, and statistical approaches

任职条件

•PhD degree in Chemistry or other closely related disciplines with 5+ years relevant work experience in pharmaceutical industry or Master degree with 10+ years of experience. Experience in major US or European pharmaceutical companies is an added advantage.

•Hands-on experience on analytical team building with strong problem-solving skills.

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

•Experienced in CMC document preparation for IND and NDA filing.

•The candidate should be a very effective communicator, interacting with key stakeholders, regulators and other technical lines and matrix teams.

•Strong written and communication skills 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

  • 1人
  • 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。

所在城市:
所任职位:
BP

企业信息

名称:
某一流上市药企
行业:
制药.生物
性质:
外商独营/外企办事处
规模:
2000-4999人

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