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        [上海 切換城市] 北京 廣州 深圳

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        分析開發研究員

        【歐康維視生物醫藥(上海)有限公司】

        8333-12500元/月

        發布日期:2021-10-19

        招1人 | 本科 | 五年以上 | 性別不限

        公司地址:歐康維視生物醫藥(上海)有限公司

        請仔細閱讀招聘信息,不要提前交保證金、材料費等額外費用。

         職位描述

        1. Work with Lab Manager to establish the R&D lab in Suzhou and participate into the operation management of Suzhou R&D center. The responsibilities may include but not limited to, selection and qualification of the R&D lab instruments, establishment of R&D lab documentation system, etc. 2. Responsible for strategy and directing the analytical development from exploratory stage through commercial launch and post-launch support assuring scientific, regulatory, and quality aspects of a project are met. The responsibilities may include but not limited to identifying Critical Quality Attributes, limits and controls for raw materials, initial/in-process and release testing.3. Works with a cross-functional team consisting of formulation, process development, production, regulatory affairs, supplier quality, raw material suppliers, etc. 4. Provides analytical interpretation of results from studies to stakeholders. 5. Management of assigned resources. 6. Keeps management apprised of accomplishments, any technical challenges, and resource constraints. 7. Participates in selection and management of CRO as necessary. 8. Responsible for completing analytical regulatory (e.g., CTD) sections and addressing regulatory agency comments for NPD as necessary. 9. Complete other tasks assigned by the superior. 


        崗位要求:

        1. Pharmaceutical science or other directly-related education background, bachelor or above. MS is preferred. 6-8 years working experience.

        2. Proficient as study director for method evaluation and validation for NPD.

        3. Demonstrated experience in applicable analytical instruments and methodology.

        4. A thorough understanding of compendial (minimally ChP and USP) and ICH (minimally Q1, Q2, Q3, and Q6) guidelines.

        5. Proven experience working with cross functional teams.

        6. Internal and external presence to identify new methodologies.

        7. Experience in issuing material specifications and test methods. 

        8. Experience in developing timelines to complete projects.

        9. Working knowledge of project management.

        10. Leadership skills with direct reports or demonstrated ability to work with indirect reports.

          

          (聯系我時,請說是在城際分類網看到的,謝謝!)
         公司簡介
        是一家總部位于中國的初創公司,致力于成為眼科領域的領先者。公司主要開發和提供處方藥物,以滿足病人、醫療專業人員和護理人員不斷發展的需求。目前,該公司已經建立了從研發到臨床試驗,再到注冊和產品營銷和銷售的經驗豐富的團隊。同時,公司正在通過內部研發和與全球合作伙伴的戰略聯盟,來建立新的藥物和技術組合,惠及更多患者。

          (聯系我時,請說是在城際分類網看到的,謝謝!)

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