岗位职责:
1.Assist risk assessment before and during technical transfer.
协助技术转移的风险评估。
2.Draft and review the technical transfer documents such as commercial-scale process description and technical reports.
起草和审核技术转移文件，例如商业化规模工艺描述、技术报告。
3.Draft and review process validation related documents such as process validation protocols and process validation reports.
起草和审核工艺验证相关文件，例如工艺验证方案、报告。
4.Draft and review process validation supporting study protocols and reports. Execute supporting studies and investigate discrepancies.
起草和审核工艺验证支持性研究的方案、报告。执行支持性研究，调查差异。
5.Responsible for process data collection and analysis.
负责工艺数据的收集和分析。
6.Responsible for setting up programs and process parameters for manufacturing equipment.
负责生产设备的工艺程序和工艺参数的设定。
7.Participate in the quality management activities, including the self-inspection, internal audit, external audit, deviations investigation and risk assessment of process change. Support for manufacturing related deviation investigation and change application. Responsible for drafting and reviewing of technical reports and memorandums.
参与质量管理活动，包括自检、内审、外审、偏差调查、工艺变更相关的风险评估。支持生产相关偏差的调查和变更申请。负责技术报告或备忘录的起草和审核。
8.Assist in collecting and trending product quality data and in-process data in each manufacturing batch. Draft and review manufacturing batch summary reports.
协助对与产品质量有关的批生产产品质量数据和工艺的数据进行汇总和趋势分析。起草并审核批生产总结报告。
9.Responsible for drafting, revising, delivering and retrieving the MST documents.
负责完成MST相关文件的维护包括文件的新建、升版、发放和回收。
10.Support the CMC submission work, including drafting and reviewing the process-related filling documents, and providing relevant data and reports.
支持CMC申报工作，包括起草和审核工艺相关的注册文件，以及提供相关文件和报告。
任职要求:
工作经验： 3年或以上
专业知识/技能：生物工程、生物化学、药剂学、制药或相关专业。
语言能力：良好的英文读写水平，听说佳
其他要求：
1.Proven ability to effectively collaborate with internal and external partners.
具备与内部或外部伙伴有效合作的能力。
2.Demonstrated excellence in technical writing in bilingual (Chinese and English).
在中英双语技术文件写作方面表现出色。
3.Fluent English in reading, writing, speaking is mandatory.
需具备良好的英文阅读、写作和口语交流能力。
4.Understanding of basic commercial-scale production process and production techniques is preferred.
了解商业化生产基本工艺和生产技术优先。
5.Understanding of common practice of biopharmaceutical process development, technical transfer and process validation is preferred.
了解工艺开发、技术转移和工艺验证的通常做法优先。
6.Understanding of basic the GMP system is preferred.
了解基本的GMP体系优先。
7.Understanding of basic design of experiment (DoE) and statistics is preferred.
了解基本的实验设计和统计分析知识优先。
8.Good communication skills.
良好的沟通能力。
9.Proficient in using Office computer software such as Word, Excel and Power Point; knowledge in statistical analysis software, e.g., JMP, minitab, is preferred.
熟练使用办公软件，如Word, Excel, Power Point等；有统计分析软件知识者优先，例如JMP、minitab。