Director, Upstream Production

岗位职责：

1. 全面管理上游各生产车间，统筹原液上游工艺生产，确保各项目高质量按期交付；
2. 负责项目上游生产物料筹备、批记录等生产文件编制管理；
3. 主导生产偏差调查、整改方案制定与落地闭环；
4. 统筹团队建设、人员培训、绩效考核等全维度人员管理工作。

任职资格：

1. 生物相关专业，硕士及以上学历；
2. 十五年以上细胞培养上游生产从业经验；
3. 熟悉 cGMP 生产合规要求；
4. 具备丰富团队管理经验，突出领导力与沟通协调能力；
5. 英语可作为工作语言。

Job Responsibilities

1. Take overall charge of all upstream production workshops, oversee upstream process manufacturing of drug substance, and ensure high-quality and on-time delivery of all projects.
2. Manage preparation of upstream production materials for projects, as well as compilation and administration of batch records and other production documents.
3. Lead investigation of production deviations, formulate corrective action plans, and drive full implementation and closure of rectifications.
4. Conduct comprehensive personnel management including team development, staff training, performance appraisal and other related work.

Job Requirements

1. Master’s degree or above in biology or related disciplines.
2. Over fifteen years of professional experience in upstream production focusing on cell culture.
3. Proficient in cGMP compliance requirements for production activities.
4. Extensive team management experience with outstanding leadership, communication and coordination capabilities.
5. Able to use English as a working language.