上海招聘

The Director or Associate Director, Manufacturing will manage establishment and operation of one of the three manufacturing departments for Bioworkshops: cell culture (USP), purification (DSP), or fill-finish (Filling).

生产部总监或副总监将负责细胞培养(USP)、纯化(DSP)和制剂灌装(Filling)中某一个车间的建设和运营。

Key responsibility for the Director or Associate Director will be ensuring timely supply of high-quality biological drug substance or finished drug products.

总监或高级总监的关键职能是确保高质量的生物制品原液或成品的及时供应。

Preferred Working Style 首要的工作风格

• Organized manager with strong prioritization and delegation skills;

有组织的领导者，具有很强的优先级和分配技能；

• 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；

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

具有较强的中英文沟通能力，能够准确地交流高技术信息，说服不同的受众群体；

Job Functions工作职责

Management 管理

· Represent Bioworkshops to external parties with focus on drug substance or drug product manufacturing;

对外代表康日百奥公司时，重点负责原液或成品生产部分的内容；

· Recruit and manage performance of Manufacturing staff for either cell culture (USP), purification (DSP), or fill-finish (Filling) team;

· 招聘和管理细胞培养(USP)、纯化(DSP)或制剂灌装(Filling)团队生产人员的绩效，；

· Accurately report status of the department for routine operation and projects;

准确报告部门日常运营和项目状态；

support the commercial operation of overall manufacturing division.

配合MFG部门的商业生产

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

· Select and manage the delivery, commissioning, and qualification of equipment/systems required for manufacturing;

负责生产设备/系统的选型并管理相应的交付，试运行和验证工作；

· Take responsibility for the capital assets assigned to the department and ensure they are maintained validated and ready-to-use;

负责本部门的固定资产管理，确保其处于已验证并随时可用的状态；

· Establish and continuously improve manufacturing procedures;

建立并持续改进生产规程；

· Manage staff across varying shift structures for on-time delivery of products in compliance with GMP;

管理不同班次的员工，确保按时交付符合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，和成品管理；以及

· Collaborate with other Operations divisions, Quality Unit, and Clients to execute technology transfers.

与其他运营部门、质量部门和客户之间进行合作以执行技术转移工作。

Quality Assurance 质量要求

· Represent manufacturing operations at audit by government authorities and Clients;

代表生产部接受政府部门和客户的审计

· Write, review, and approve procedures related to manufacturing operations;

编写、审阅和批准与生产操作相关的规程；

· 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(优先考虑生物学或化学方向)

Essential Experience 必要经验

· Minimum of 10 years responsibility in manufacture of therapeutic biologics;

至少10年的治疗性生物制品生产经验；

· At least 5 years of operational experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up;

至少5年在受监管的生物制药企业的运营经验，并有工厂起运经验；

· Previous experience in designing and writing quality system documents related to manufacturing: SOPs, Master Batch Records, material specifications;

以往有设计和编写与生产相关的质量体系文件经验:sop、主批记录、物料标准；

· Previous responsibility for the design, equipment selection, start-up, and qualification of manufacturing facilities use for bulk drug substance and/or finished biological products;

以往有负责生物制品原液和/或成品生产设施的设计、设备选型、启用和验证经验；

· Management responsibility for operation of a biologics manufacturing facility operating at least 2,000L in scale or filling batches at least 20,000 units;

具有生产规模至少为2000升或灌装能力至少为20000瓶/批的生物制品生产车间管理经验；

· Experience in managing project teams of at least 15 people;

具有管理至少15人的项目团队的经验

Preferred Experience 优先考虑

· Expert knowledge of Good Manufacturing Practice of China, EU, and USA related to biologic products, clinical trial materials, and/or sterile aseptic products;

对于中国、欧盟和美国在生物制品、临床试验样品和/或无菌制剂方面的GMP规范具有专业的认知；

· Advanced degree in biological science (Masters or PhD).

具有生物科学高等学位(硕士或博士)。

Bioworkshops Suzhou is a biopharmaceutical company with headquarters in Hong Kong which develops first-in-class and best-in-class antibody products for China and the world in collaboration with international partners. We develop and manufacture clinical drug substances and drug products produced by cell culture to international standards. Our Mission is to consistently develop and achieve approval of biologic products faster than anyone else in China through expert application of manufacturing science.
The Company has recently acquired a 28,000 sq. meter building and land in Suzhou and is investing over RMB300M in building state-of-the art development and clinical manufacturing facilities in 2019 and will be well on the way towards our goal of obtaining the first IND approval in 2020.

康日百奥（苏州）是一家总部位于香港的抗体研发企业，致力于汇同其国际合作伙伴为中国乃至全球带来行业领先和同类之最的新药产品。我们遵照国际标准开发基于细胞培养的生产工艺来进行临床用原液和成品的生产。我们的使命是通过制造科学的专业应用，比中国其他竞争对手更快速的完成生物制品的开发及批准。
我们公司最近在苏州收购了一栋总建筑面积28000平米的大楼及土地，投资了超过3亿元人民币拟在2019年建成具备先进水平的研发和临床样品生产基地并将在2020年实现获得首个IND批准的目标。

Talented, productive experts
极具才华且成果卓著的专业团队
The founding members of Bioworkshops are industrial veterans from Australia and China who have been starting-up and leading biologics product development companies and biologics manufacturing organizations all over the world for more than 20 years. In the past five years alone, the founding team has successfully developed over 10 new antibody products for US, Australia, and China markets and have completed successful design, build, and start-up of four biologics development and manufacturing centers:
Clinical and commercial production.
Inspected for compliance against US-FDA, NMPA, TFDA, and TGA regulations to file CTA/IND and commercial products.
We have quickly established a start-up team and are recruiting more expert staff to exceed 150 employees within the coming year.

康日百奥的创始成员是来自澳大利亚和中国的行业资深人士，在过去20余年的时间里在世界范围内创办并领导了多个生物制品研发及生产企业。仅在过去的五年中，创始团队就成功为美国，澳大利亚和中国市场开发了10多种新型抗体产品，并同时成功完成了四个生物制品研发和制造中心的设计、施工和启用：
临床和商业化生产
通过了美国食品及药物监督管理局，中国药品监督管理局，台湾卫生福利食品药物管理署和澳洲医疗用品监管局针对新药临床申报和药品商业化报产的现场检查
我们已快速的建立起了一支初创团队并将持续的招募更多的专业人士加入以期在明天扩展成为一个规模达150人的团队。

Management of Quality
质量管理
Predictable, excellent performance requires deliberate management of quality with commitment to continuous improvement. Bioworkshops Quality Management System encompasses all business operations with particular focus on pharmaceutical product quality in development and manufacturing to comply with Chinese, European, and American Good Manufacturing Practice.
可预见且卓越的表现需要深入***的质量管理，并致力于在过程中不断的改进。康日百奥的质量管理体系贯穿于公司的整个商业运营过程中，并尤其注重医药产品在研发和生产过程中的质量，以符合中国，欧洲和美国GMP规范。

Innovative R&D Hub and Productive international-standard facilities
创新型研发中心和高产能国际标准厂房
Located within in the heart of Suzhou Industrial Park, we are building high-capacity drug discovery, development and manufacturing facilities for
Development capacity for 8-12 INDs per year.
Clinical drug substance manufacturing to 2,000L.
Aseptic filling of liquid product into vials.
Best in class bioprocess and analytical performance.

我们位于苏州工业园区的核心区域，正在建设大容量的新药发现，开发和生产基地：
建立具备每年开发8-12个IND项目的能力
2000L临床用原液生产
无菌水针制剂灌装
一流的的生物工艺和分析能力

Bioworkshops Founding Values
康日百奥价值观
We believe that strong culture and alignment of purpose are essential in business. The core principles maintained by Bioworkshops are:
Excellence in biologics innovation and development.
Strong relationships based on honesty.
Sustainability measured by workplace safety, impact on the environment, and longevity in business.
Enthusiasm for ambitious goals and creative solutions.
Respect for the sustained effort required to achieve ambitious goals in our industry.
我们相信强有力的文化和共同的目标对于企业至关重要。康日百奥所维系的核心原则是：
卓越的生物制品创新和研发
牢固的关系源自诚信
可持续性通过安全生产，环境影响和长久永续的商业模式来衡量
热衷于树立远大目标并提出创造性解决方案
敬畏那些在本行业中为了实现宏伟目标而持之以恒付出的努力