Our client is a biopharmaceutical companywhich develops first-in-class and best-in-class antibody products for China and the world in collaboration with international partners.

The main target is to developand manufacture clinical drug substances and drug products produced by cell culture to international standards. Facility size approx 28,000 sq. meter building and land and they are investing over RMB300M in building state-of-the art development and clinical manufacturing facilities in 2019 and will be well on the way towards obtaining the first IND approval in 2020.

新药发现，开发和生产基地

职责描述：

The Senior Director, Manufacturing will lead the building and operation of the manufacturing division. The scope of manufacturing encompasses cell culture (USP), purification (DSP, and fill-finish (Filling).

制造部高级总监将领导生产部的建设和运作。生产范围包括细胞培养(USP)、纯化(DSP)和制剂灌装(Filling)。

Primary responsibility for the Senior Director will be ensuring timely supply of high-quality biological drug substance and finished drug products.

高级总监的主要职责将是确保高质量的生物制品原液和成品的及时供应。

Preferred Working Style

首要的工作风格

Organized leader with strong prioritization and delegation skills;

有组织的领导者，具有很强的优先级和工作分配技能

Enjoy working in highly structured system to achieve high operational efficiency and consistent product quality;

享受工作于高度结构化的系统中，以实现高运营效率和一致的产品质量

Excellent communication skills in Chinese and English to accurately exchange highly technical information and persuade diverse audience groups;

优秀的中英文沟通能力，准确交流高技术信息，说服不同的受众群体

Strong business acumen.

很强的商业头脑

Job Functions工作职责

Management 管理

Member of the Company’s Senior Management Team;

公司高层管理团队成员

Responsible for commercia operation of manufacturing division.

负责商业化生产的日常运营。

Site Safety and Environmental compliance

工作场所安全和环境合规

Develop and maintain a culture of safe working practices through personal leadership and compliance with Company procedures; and

遵守公司安全环保规章制度，身体力行的建立并自觉维护安全工作的企业文化

Manufacturing 生产

Establish and continuously improve manufacturing procedures, processes, and related equipment.

建立并持续改进生产操作步骤、工艺和相关设备。

Optimize manufacturing output and labor efficiency across varying shift structures while meeting required safety and quality levels;

在满足所需的安全和质量水平的同时，通过轮班结构的优化来提高生产能力和工作效率

Lead reliable, cost-effective, and efficient operation of the Manufacturing division facilities encompassing drug substance (USP and DSP) and drug product departments to deliver batches of product in compliance with GMP and on time;

领导包括原液(USP和DSP)和成品生产在内的生产车间通过可靠、经济、高效的运作，按时交付符合GMP要求的产品

Coordinate ordering of starting materials, management of intermediates, and finished products; and

协调原材料采购，中间品管理，成品管理；以及

Lead close collaboration with other Operations divisions, Quality Unit, and Clients to execute technology transfers.

领导与其他运营部门、质量部门和客户间的紧密合作，执行技术转移工作

Quality Assurance 质量保证

Represent manufacturing operations at audit by government authorities and Clients;

代表生产部门接受政府部门和客户的审计

Lead creation of the Company’s policies and procedures related to manufacturing operations;

领导制定公司与生产运营相关的政策和规程

Comply with Good Manufacturing Practice for the intended countries of product distribution;

遵守产品分销目标国家的GMP规范

Qualifications 任职资格

B.S. (preferably Biology or Chemistry)

学士学位(优先考虑生物学或化学方向)

Advanced degree in biological science (Masters or PhD)

生物科学相关高等学位(硕士或博士)

Essential Experience必要经验

Minimum of 15 years responsibility in manufacture of therapeutic biologics;

至少15年的治疗性生物制品生产经验

At least 10 years of operational experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up;

至少有10年在受监管的生物制药企业的运营经验，并有工厂初创经验

At least 2 years operational experience in manufacturing of mAbs;

至少2年以上单克隆抗体生产操作经验

Represented manufacturing function at a regulatory inspection by government agencies (NMPA/CFDA, US-FDA, and EMA or similar);

代表生产部门接受政府机构的监管检查(NMPA/CFDA、US-FDA、EMA或类似机构)

Management responsibility for operation of a biologics manufacturing facility operating at least 2,000L in scale.;

管理过生产规模至少为2000升的生物制品产线

Preferred Experience 优先考虑

Thorough understanding of MAb development, manufacturing, and analytical process;

对单克隆抗体产品的开发、生产和分析过程具备全面的了解

Sound understanding of PIC/S guidelines and recommendations; 对PIC/S的指导原则和建议有充分的理解