锦鲤求职岗位描述
教育程度/经验Education background/ Experience
1、本科及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员。
Bachelor degree or above, major in biology, chemistry, pharmaceutical engineering or equivalent work experience.
2、本科至少需要5年及以上工作经验，硕士3年以上工作经验，博士2年以上工作经验。
Undergraduate at least 5 years of work experience or more, master 's degree at least 3 years of work experience, doctor at least 2 year of work experience.
3、具有下游纯化等GMP大规模生产操作的相关知识/经验。
Knowledge/experience in GMP large-scale manufacturing operations such as downstream purification.
4、具有优秀的沟通表达能力以及良好的口头和书面英语水平。
Excellent communication skills and good oral and written English.
5、具有较好的管理和领导能力者优先。
Good management and leadership are preferred.
工作职责 Job Responsibility
1、负责所在Group的整体运营管理，带领团队完成下游纯化生产活动，确保安全（Safety）、质量（Quality）、交付（Delivery）及成本（Cost）目标达成，并保证所有生产活动符合现行GMP要求。
Lead the overall operation of the group and
drive the successful execution of downstream purification manufacturing
activities, ensuring achievement of safety, quality, delivery, and cost
objectives while maintaining compliance with current GMP requirements.
2、制定并实施团队人才发展计划，包括但不限于专业技能、GMP意识、领导力及岗位能力建设，推动高绩效团队建设和人才梯队发展，培养关键岗位后备人才。
Develop and implement team development
plans, including but not limited to technical skills, GMP awareness, leadership
capability, and competency development, to build a high-performing team and
establish a sustainable talent pipeline.
3、负责团队日常管理及资源协调，及时向管理层汇报重大异常；主导或参与复杂异常事件分析处理、偏差调查、变更管理及CAPA实施，推动问题根本解决并持续提升质量体系合规性。
Manage daily team operations and resource
coordination, and promptly communicate significant issues to management. Lead
or participate in complex event investigations, deviation management, change
control activities, and CAPA implementation to ensure effective issue
resolution and continuous quality improvement.
4、主导或审核GMP文件的编制、修订及持续优化，包括但不限于SOP、MBR、URS、FAT、SAT等；确保生产记录及相关文件符合数据完整性、合规性及质量要求。
Lead or review the preparation, revision,
and continuous improvement of GMP documentation, including but not limited to
SOPs, MBRs, URSs, FATs, and SATs. Ensure production records and related
documentation meet data integrity, compliance, and quality requirements.
5、识别运营过程中的风险、浪费及瓶颈，主导精益改善（Lean）、Kaizen及持续改进项目，推动生产效率提升、资源优化利用及运营绩效持续改善。
Identify operational risks, waste, and
bottlenecks. Lead Lean, Kaizen, and continuous improvement initiatives to
enhance productivity, optimize resource utilization, and drive operational
excellence.
6、负责项目的规划、组织与推进，包括但不限于技术转移（Tech Transfer）、PPQ、客户审计、工艺优化及其他业务关键项目；统筹跨职能团队协作与资源协调，确保项目按计划、高质量完成并实现既定业务目标。
Lead the planning, coordination, and
execution of projects, including but not limited to technology transfer, PPQ
activities, customer audits, process optimization, and other critical business
initiatives. Collaborate with cross-functional teams and align resources to
ensure successful project delivery in accordance with timeline, quality, and
business objectives.
7、负责团队绩效管理、员工敬业度提升及组织文化建设，营造积极、高效、合规的工作氛围，促进团队协作与组织能力持续提升。
Drive team performance management, employee
engagement, and organizational culture development. Foster a positive,
efficient, and compliant working environment that supports teamwork and
continuous capability growth.