版權所有 ? 北京天廣實生物技術股份有限公司

京ICP備 09113705 號   網站建設:中企動力 北京

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職位詳細

職位名稱:

生產資深總監

薪資:
面議
工作地點:
北京市-北京市-大興區
所屬部門:
工藝與生產部
招聘人數:
1
工作性質:
全職
工作年限:
5-10年
學歷:
碩士
年齡:
性別:
不限
發布時間:
2021/03/31 15:18
瀏覽量:
職位描述:

Senior Director of Manufacturing

作為生產資深總監,您將領導DS / DP制造和設施運營團隊,并監督生產運作,以通過商業化支持臨床研究。該領導作為專家遵守生產和(cGMP)的規范,合法合規指導生產團隊和生產流程,以確保安全,高效,按時生產并交付高質量產品,同時遵守cGMP和法規要求

As a Senior Director of Manufacturing, you will lead DS/DP manufacturing and facility operation teams and oversee manufacturing operations to support the clinical studies through commercialization. This leadership role will serve as manufacturing and Good Manufacturing Practices (cGMP) compliance subject matter expert and direct manufacturing team and processes to ensure safe, efficient, and on-time production and deliver high quality products while complying with cGMP and regulatory requirements.

職位概述:

Position Summary

3.1指導和管理所有日常GMP制造操作,包括技術轉讓,日程安排,GMP活動,后勤,文檔審查,變更控制,設施操作,EHS

 Direct and manage all day-to-day GMP manufacturing operations, including tech transfer, scheduling, GMP campaigns, logistics, document review, change controls, facility operation, EHS, and etc.

3.2 與研發團隊有效合作,以確保在不久的將來將無缺陷的過程轉移到當前的臨床生產和制造中

Work effectively with process development teams to ensure a flawless process transfer for current clinical manufacturing and commercial manufacturing in the near future.

3.3 提供技術和法規指導,以確保生產過程是在有效且合規的環境進行。交付用于臨床研究,法規批準和商業的產品

Provides technical and regulatory leadership to assure an effective and compliant environment for manufacturing processes. Deliver products for clinical studies, regulatory approval and Commercial launch.

3.4 為建設一個先進的、符合GMP規范的工廠,在設計、施工、調試、認證和啟動過程中提供戰略和技術領導。

Provides strategic and technical leadership throughout design, construction, commissioning, qualification, and startup for a state-of-the-art GMP facility. 

3.5 開發和管理DS/DP和設備運營預算。與產品開發和供應鏈合作,利用卓越運營工具促進生產效率、質量和成本的持續改善

Develop and manage DS/DP and facility operation budgets. Utilize Operational Excellence tools to facilitate continuous improvement of production efficiency, quality and cost in partnership with product development and supply chain.

3.6 在現場樹立“安全第一”的文化,提高我們的安全意識水平和通過培訓改變所有員工的安全行為

Establish a “Safety First” culture on the site and improve safety performance by championing our level of awareness and changing all staff safety behaviors by training.

3.7通過業務增長來培養,發展和留住員工。建立和跟蹤KPI指標以評估團隊績效。

 Build, develop and retain staff through growth of the operation. Establish and track KPI metrics to evaluate team performance.

3.8 參加風險管理活動。提供與識別和緩解設備和制造過程風險有關的技術專業知識。

Participate in Risk Management activities. Provide technical expertise pertaining to the identification and mitigation of equipment and manufacturing process risks.

3.9 能夠做出適當的判斷,并在戰略和戰術思維/計劃之間快速轉換,管理多個緊要事項以實現目標。

Ability to make appropriate judgment and rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve the objectives.

任職條件:

Position Qualification:

1、生命科學或相關生物技術制造學科碩士及以上學歷。

Ph.D. or M.S degree in life sciences or related biotechnology manufacturing discipline.

2、8 - 10年以上cGMP環境下和全球法規要求下的制藥/生物制藥生產管理經驗。

8+ to 10+ years of management experience in pharmaceutical/biopharmaceutical manufacturing in a cGMP environment and global regulatory expectations.

3、熟悉NMPA, FDA和EMEA法規,ICH指南和cGMP。熟悉生產許可證和GMP認證要求;有申請和現場審核經驗。

Familiar with NMPA, FDA and EMEA regulations, ICH guidelines and cGMP. Familiar with the requirements of Manufacture License and GMP Certification; Experienced in application and site audition processes.

4、在臨床或商業生產操作和設施管理方面有良好的cGMP記錄。有較強的科學背景和生物制品方面的專業知識,對GMP操作中CMC工藝有深入的了解者優先。

Proven track records in cGMP at clinical or commercial manufacturing operations and facility management. Strong scientific background and expertise in biologics products with thorough understanding of CMC processes for GMP operations preferred.

5、為生產、質量、驗證和供應鏈等多功能團隊提供科學、工程和合規方面的專業知識,以推動復雜項目的完成。

Proven ability in providing scientific, engineering and compliance expertise to multi-functional teams in manufacturing, quality, validation and supply chain to advance complex projects to completion.

6、熟悉cGMP生產環境中的變更控制系統和變更技術評估。

Familiar with change control systems and technical assessment of change in a cGMP production environment.

7、具有很強的領導能力,優秀的溝通能力和團隊合作精神。能夠與直接下屬、同事和高級管理層建立建設性和高效的人際關系。

Demonstrate strong leadership, excellent communication skill and great team player. Ability to develop constructive and effective relationships with direct reports, colleagues and senior management.

 

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