Job functions include, but are not limited to the following:

工作职责包括但不限于：

Technical writing

• Develop and provide support for professional and user-friendly templates and forms that increase efficiency, consistency, and corporate identity;
• Create and edit quality management system documents (e.g. Policy, Standards, SOPs, and forms) and other technical documents (e.g. Commercial Proposals, development summary reports, press releases, and website content) in English and Chinese, maintain and revise templates for these when required, and drive consistency, efficiency, and identification of best practices for these documents;
• Apply excellent grammar, spelling, punctuation, and language usage skills to write documents quickly, simply, and clearly in English and Chinese;
• Liaise with colleagues to create system-related manuals and other training materials using conceptual, topic-based, task-oriented reference information;
• Ensure quality standards and consistency in language, visuals, graphics, and format;
• Collaborate with other departments to author cross-functional documents such as Site Master File, Drug Master File sections, CMC sections for IND applications, audit responses, project reports, and other documents as needed;
• Perform and write thorough risk assessments on behalf of Analytical Development, the Material Review Board, and other groups, as needed; and
• Ensure accuracy, completeness, and clear presentation of all authored and reviewed documents.

Quality Assurance 质量要求

• Comply with the Company Quality Management Systems;

遵守公司发质量管理体系;

• Author new and revise documents and provide input to the scope of documentation impacted from quality-related issues (change control, CAPA, and deviations).

• Assist with Document Control function for the company (i.e. issue, recall, and archiving of controlled documents)

Qualifications 任职资格

• B.S. (preferably related to life sciences.)

Essential Experience 必要经验

• Minimum of 4 years of experience with Technical Writing for high-technology manufacturing industry, preferably in the Biopharma/pharmaceutical industry;

• Expert user of Microsoft Office applications (MS Word, Excel, Outlook) and Adobe Acrobat to create and edit document templates and editable forms;

• Proven experience to work both independently and as part of a team in a fast-paced, deadline-driven environment; and

• Proven ability to develop user manuals, instructions, and training documents for technical audiences starting from various conceptual, topic-based, and task-oriented reference information;

Preferred Experience 优先考虑

• Advance qualification in English or Chinese language and/or visual design;

• Sound working knowledge of current Good Manufacturing Practices (cGMP), and government regulations related to pharmaceutical products;

• Understand user experience and user accessibility principles;

• Familiar with use of electronic Document Management Systems (eDMS);

• Ability to learn and teach complex ideas quickly, accurately, and effectively.

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