Job Functions工作职责

Leadership领导力

• Assist purification and process development group to meet project timelines, departmental goals; 协助纯化和工艺开发小组完成项目节点和部门目标;

Site Safety and Environmental compliance现场安全和环境合规

• Take part in the site safety;参与到工作现场的安全中。

• Adhere to the Company’s safety and environmental protection procedures. 遵守公司的安全环保程序。

Process Development工艺开发

• Research the purification of protein, process development and optimization.

研究蛋白质的纯化、完成工艺开发和优化。

• Develop process plan, provide clear prescription process, and guide the workshop to complete manufacture.

制定工艺计划，提供明确的工艺流程，指导车间完成生产。

• Prepare qualified samples to ensure the smooth operation of pre-clinical.

准备合格的样品，确保临床前的顺利进行。

• Draft the original experiment record and filing documents for IND.

为IND起草原始实验记录和归档文件。

• Collecting the supporting documents of materials.

收集物料的证明文件。

Qualifications任职资格

• Major in Pharmaceutics, Pharmaceutical Science or related field;

药剂学、药学或者其他相关专业。

• Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.

相关专业的本科或硕士学历。

Essential Experience必要经验

• BS degree with a minimum of 0~3 years and MS degree with a minimum of 0~2 years of large Biomolecule purification experience;

本科0~3年，硕士0~2年相关生物大分子制剂经验

• Mastered the theoretical knowledge of pharmaceutical;

掌握药学的理论知识

• Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing;

• 熟悉文献检索及相关信息检查，熟悉IND备案。

• Strong communication and execution ability;

较强的沟通和执行能力。

• Ability to bear certain stresses. Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

熟练使用Microsoft Office办公软件(Word、Excel、Powerpoint、Project、Outlook)

Preferred Experience优先考虑

• Project management of CMC filing for US, EU, and China IND/CTA;

具有美国、欧盟和中国项目申报方面的管理经验。

• Familiar with office software and proficient in reading professional English;

熟悉办公软件，熟练阅读专业英语;

• Sound knowledge of Good Manufacturing Practices including NMPA, PIC/S, and US-FDA guidelines with focus on biologic API production for clinical trials;

具备良好的生产实践知识，并注重关于API产品的临床试验的NMPA、PIC/S和US-FDA法规指南，

• Project management training;

具有项目管理能力

• Formal root-cause analysis training;

严谨的问题分析能力

上班地址：苏悦广场

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骨髓的质量管理，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