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    職位名稱: 著名制藥企業生產副總裁 工作地點: 山東省煙臺市
    工資待遇: 招聘人數: 2人
    發布日期: 2019-03-14    

    具體要求

    崗位名稱2:著名制藥企業生產副總裁

    崗位職責:

    1、Oversee and manage GMP manufacturing facilities to support IND filing and clinical trials for therapeutic 

    antibodies, antibody-drug conjugates, and recombinant protein projects.

    監督和管理 GMP 生產設施以支持治療性抗體、抗體藥物偶聯和重組蛋白工程的申 報和臨床實驗;

    2、Allocate resources to achieve objectives and ensure the production schedules are met.

    分配資源以實現目標和確保生產計劃得以實現;

    3、Ensure critical manufacturing documentation is prepared timely such as BPR’s, SOP’s and specifications.

    確保及時編制關鍵生產文件,例如 BRP,SOP 和規范;

    4、Oversee raw material inventory, cleaning, and gowning management to ensure compliance with current GMP policies and safety practices.

    監督原材料庫存、清洗管理以確保符合現行 GMP 政策和安全措施;

    5、Provide technical expertise for manufacturing deviations, change control, CAPA and assist QC OOS investigations by working in concert with Quality Assurance to ensure proper disposition of affected materials.

    通過與 QA 工作提供制造技術變更控制、偏差、CAPA 和協助 QC OOS 調查以確保適 當處理受影響的材料;

    6、Support operational budgets, cost controls and resource planning to meet production objectives.

    提供業務運算、成本控制和資源計劃以滿足生產目標。

    任職要求:

    1、Advanced degree in a relevant scientific discipline (i.e. chemistry, biology, chemical or pharmaceutical engineering).

    具有相關科學學科的碩士學位(如化學、生物、化學或制藥工程);

    2、More than 10 years’ experience in biologics manufacturing.

    10年以上生物制品生產經驗;

    3、Ability to managing GMP manufacturing operation from large scale mammalian cell culture to fill/finish.

    有能力管理大規模哺乳動物細胞從培養到完成的 GMP 生產操作;

    4、In-depth knowledge of drug substance and/or drug product manufacturing and engineering aspects of larger scale operations.

    深入了解大規模生產的原料藥和藥物產品制造和工程方面的知識;

    5、Hands on GMP experience with all phases of drug development and manufacturing, as well as in-depth knowledge and full understanding of GMP requirements.

    熟悉藥品開發和制造的各個階段的 GMP 經驗,深入和全面了解 GMP 要求;

    6、Strong leadership and excellent verbal & written communication skills.

    優秀的領導能力和優秀的口頭和書面溝通能力;

    7、Ability to support regulatory requirements for regulatory agency approval.

    支持監管機構批準法規要求的能力。

    8、Fluent in English and Chinese is required.

    流利的中英文。

    工作地點:山東省煙臺市

    請將個人簡歷投遞至:[email protected]

    薪資福利待遇:面議


    選擇簡歷

    地址:中國 濟南 歷下區濼源大街150號中信廣場716室 電話:0531-85180704/05/11 傳真:0531-86160609

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