上游生产高级工程师

1.1 负责项目管理，包括与研发部门和CMC团队进行技术转移和风险评估工作，领导多个团队进行上游细胞培养生产活动，确保批生产活动符合GMP的要求。

Be responsible for project management including communicate about technical transfer and risk assessment with PD department and CMC team. Lead multiple team perform cell culture GMP production and so on. Make sure to complete batch production activities under GMP compliance.

1.2 负责监督车间现场管理，确保GMP生产活动有序高效执行。

Responsible for facility floor management, to make sure GMP production activities are carried out in an orderly and efficient manner.

1.3 负责审阅GMP相关文件，包括但不限于SOP/MBR/RPP/PFD/URS/FAT/SAT，撰写和审核批生产记录。

Review GMP documents including but not limited to SOP/MBR/RPP/PFD/URS/FAT/SAT, and review the executed batch record.

1.4 负责定期与客户沟通并汇报项目进展，领导解决生产过程中出现的问题。

Be responsible for communicating with client about project progress, lead to solve the issues in production process.

1.5 领导或者参与偏差调查和审核工作、变更实行、纠正和预防措施的执行。

Lead or take part in deviation investigation, change control and CAPAs execution.

1.6 负责维护GMP车间的安全运行状态，监督日常生产现场管理，必要时负责进行组内员工的安全教育及监督。

Keep a safe environment in GMP facility. Be responsible for supervising of the daily production management on the spot. Be responsible for performing the safety education and supervision for whole staffs within the team if needed.

1.7 与工程或相关部门沟通协调设备，设施，厂房的维护维修及计量工作。

Communicate and coordinate with ENG or other department about equipment and facility maintenance and metrology affairs.

1.8 承担指定的跨部门沟通工作，包括但不限于组织会议，及时传达共识，促进与其他部门沟通解决流程或合作问题。

Take the assigned cross functional communication tasks, including but not limited to arranging meetings, delivering alignment information in time. Keep communication with other departments to resolve process or cooperation issues.

1.9 负责生产物料管理，必要时与供应商或经销商等沟通联系。

Be responsible for project material management. Contact suppliers and vendors if required.

1.10 建立所有下属个人能力矩阵表，并制定出年度培训计划，保证组内人员有资质有能力执行所需操作。

Be responsible for ensuring that all subordinates have been trained in time and qualified to perform the operation.

1.11 主动开展业务优化并持续改进，降低生产成本，提高生产效率。

Be proactive to optimize and improve the operation continuously, reduce the production cost and enhance productivity.

1.12 负责指导并发展下属员工，领导团队建设。

Be responsible for mentoring and cultivating subordinates and team building.

1.13 负责组内及部门的日常行政管理事务，负责上游生产平台建设，包括技术迭代，新技术的引入。

Be responsible for managing the group or department routine affairs, and be responsible for USP platform upgrade, and introduction of new cell culture technology.

1.14 完成上级交待的其他相关任务

Perform the task assigned by leader.

2.0 人员资质 PERSONAL QUALIFICATION

2.1 专科学历6年以上/本科学历5年以上/硕士学历4年以上/博士学历3年以上，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。

College with minimum 6 years working experience, bachelor with minimum 5 years, master with minimum 4 years, doctor with 3 years, majored in Biology, Chemistry, Pharmaceutical Engineering, related Science major or person with equivalent experiences.

2.2 具有3年以上哺乳动物细胞培养或3年以上管理工作经验，具备2年以上GMP管理经验者优先。

Persons with minimum 3 year cell culture experience or 3 year production management experience etc. and 2 year experience in GMP management is preferred.

2.3 具有较好的沟通能力和理解能力，良好的英文的听，说，读、写能力。

Have good communication and understanding ability, good English skill in listening, speaking, reading and writing.

2.4 具有吃苦耐劳的品质及良好的身体素质。

Have the spirit to bear hardships and hard work and good physical quality.

2.5 有团队协作精神，工作积极向上并具有良好的学习能力。

Have team work spirit with an optimistic work attitude and good learning ability.