工作职责: MST(Manufacturing Science Transferring)Manager 岗位职责 Job responsibilities:: 1. 负责从研发部门或客户到生产部门的多肽技术转移,制定详细的技术转移计划,确保生产工艺的稳定性和可重复性,并符合GMP规范要求; Responsible for peptide process transfer from R & D department or customer to production department, formulate detailed technology transfer plan to ensure the stability and repeatability of production process and comply with GMP specifications. 2. 参与和指导工艺开发工作,确认关键工艺参数,优化生产工艺以提高效率和产品质量。 Participate in and guide process development, confirm key process parameters, optimize production process to improve efficiency and product quality. 3. 为生产部门提供现场技术支持,分析和解决生产中的工艺难题,参与优化生产流程; Provide on-site technical support for manufacturing department, analyze and solve the process problems in production, and participate in optimizing the production process. 4. 参与编写和审核技术相关文件,包括但不限于实验方案、实验总结、工艺规程、技术转移文件和技术报告等; Participate in the preparation and review of technology-related documents, including but not limited to experimental schemes, experimental summaries, process procedures, technology transfer documents and technical reports. 5. 参与偏差及OOS调查和根本原因分析,提供相关调查数据,并参与制定纠正和预防措施;根据需求,参加与客户的项目讨论会。 Participate in deviation and OOS investigation and root cause analysis, provide relevant investigation data, and participate in the establishment of corrective and preventive measures. Participate in project meeting with customers as required. 6. 为生产操作及管理人员提供日常技术培训,提高团队整体技术水平; Provide daily technical training for production operations and management personnel to improve the overall technical level of the team. 7. 与研发、生产、QC、QA、PM等部门紧密合作,参与技术讨论和产品指标评估,确保产品符合质量要求; Work closely with R&D, manufacturing, QC, QA, PM and other departments to participate in technical discussion and product index evaluation to ensure that products meet quality requirements. 8. 持续关注多肽行业的技术发展动态,积极推进技术创新和生产工艺改进。 Continue to pay attention to the technological development of the peptide industry, and actively promote technological innovation and manufacturing process improvement. 任职资格: 任职要求Job Requirements : 1. 化学工程、制药工程、生物工程、药学、有机化学等相关专业硕士及以上学历; Master‘s degree or above in chemical engineering, pharmaceutical engineering, biological engineering, pharmacy, organic chemistry, etc. 2. 具有至少5年以上多肽行业工作经验,熟悉GMP规范; At least 5 years working experience in the peptide industry, familiar with GMP rules. 3. 具备较强的工艺开发与优化能力,熟悉车间放大生产,有技术转移经验者优先; Have strong ability of process development and optimization, familiar with workshop scale-up production, experience in technology transfer is preferred. 4. 良好的沟通和跨部门合作能力,能独立带领团队解决问题; Good communication and cross-departmental cooperation skills, able to independently lead the team to solve problems. 5. 英语听说读写能力良好,能阅读和撰写英文技术文件,能用英语进行日常交流。 Good English listening, speaking, reading and writing skills, able to read and write technical documents in English, able to carry out daily communication in English.