上海招聘

Job Functions工作职责

  

Including but not limited to包括但不限于：

Laboratory equipment 实验室仪器

  

• Responsible for managing and performing equipment qualifications and calibration

• 负责管理和执行设备的确认、校准活动

• Draft instrument use and maintenance procedures, perform routine instrument maintenance and PM as required to maintain testing equipment at a validation state to ensure accuracy of test results

• 制定仪器使用和维护策略，按要求执行仪器的日常维护和PM，确保仪器处于验证状态，以保证检测结果的准确。

        

Testing 检测

  

• Execute the physiochemical tests contain samples from release, stability and IPT. Finish the related record writing and reviewing.

• 按要求执行包括放行、稳定性和IPT等样品的理化项目的检测，及时完成相关记录的书写和复核。

• Ensure the timely disposal of tested samples

• 确保及时处理测试样品

• Identify the event in the test process, investigate and find the root cause, make the CAPA plan in time.

• 敏锐识别检测过程中的异常情况，合规及时的完成根本原因的调查，并制定解决策略。

• Create and review methods and procedures for completeness and accuracy

• 创建并审查方法和程序的完整性和准确性

• Comply with safety guidelines

• 遵守安全准则

• Learn and comply with GLP, and cGMPs, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books.

• 学习并遵守GLP和cGMP，包括但不限于培训记录，实验室笔记本，书面程序，设备监控系统和实验室日志的维护。

                        

Method transfer and validation

  

• Draft and review method transfer, method validation protocol and report. Then execute them effectively. Judge the effectiveness of the test transfer and validation accurately.

• 独立起草审核方法转移、方法验证方案和报告，有效执行方法转移和验证活动，并能够准确判断方法转移和验证是否达到预期目的。

• Draft the related SOPs and data management strategy according to the result of method transfer and validation.

• 根据方法转移和验证的结果制定相关的操作规程和数据管控策略。

        

Team work团队协作

  

• Guide and train some new employees about the compliance and technical.

• 对新员工和组内成员给予合规和技术的培训和指导

• Work with team members to finish the test and other issues in lab.

• 与团队其它成员共同完成检测、实验室运营等相关工作。

• Finish the routine lab management issues, contain consumable purchase application, reagent management.

• 有效完成实验室日常管理工作，如耗材的申购，试剂的管理。

• Capability of identifying the risks.

• 具有识别风险的能力。

• Authoring for new and revise documents, participation on investigation teams, input to quality systems (change control, CAPA, and deviations)

• 编写新的和修订的文件，参加调查团队，输入质量体系（变更控制，CAPA和偏差）

                      

Qualifications资质要求

  

• Bachelor degree.

• 学士学位

• Pharmaceutical related Major

• 药学、生物、化学相关专业

        

Essential Experience工作经验

  

• Minimum 2 years of relevant experience in a cGMP QC operations.

• 至少有2年cGMP质量控制操作相关经验。

• Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.

• 需要出色的沟通技巧（口头和书面）和人际交往能力。英文和中文流利。

• Excellent structured organization skills to meet tight deadline.

• 出色的结构化组织技能，可以在紧迫的期限内完成任务。

            

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