具体要求

岗位名称2：著名制药企业生产副总裁

岗位职责：

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

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

监督和管理 GMP 生产设施以支持治疗性抗体、抗体药物偶联和重组蛋白工程的申 报和临床实验；

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

分配资源以实现目标和确保生产计划得以实现；

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

确保及时编制关键生产文件，例如 BRP,SOP 和规范；

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

监督原材料库存、清洗管理以确保符合现行 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.

通过与 QA 工作提供制造技术变更控制、偏差、CAPA 和协助 QC OOS 调查以确保适 当处理受影响的材料；

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

提供业务运算、成本控制和资源计划以满足生产目标。

任职要求：

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

具有相关科学学科的硕士学位（如化学、生物、化学或制药工程）；

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

10年以上生物制品生产经验；

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

有能力管理大规模哺乳动物细胞从培养到完成的 GMP 生产操作；

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

深入了解大规模生产的原料药和药物产品制造和工程方面的知识；

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.

熟悉药品开发和制造的各个阶段的 GMP 经验，深入和全面了解 GMP 要求；

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

优秀的领导能力和优秀的口头和书面沟通能力；

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

支持监管机构批准法规要求的能力。

8、Fluent in English and Chinese is required.

流利的中英文。

工作地点：山东省烟台市

请将个人简历投递至：Resume.shandong@fesco.com.cn

薪资福利待遇：面议