This role will oversee operational management, team development, and strategic planning for the company's drug substance production facilities (including upstream cell culture and downstream purification process). Key responsibilities include ensuring all manufacturing activities strictly comply with cGMP regulations, company SOPs, and quality standards, while efficiently completing clinical and commercialization-stage production tasks. The incumbent will also drive continuous innovation and process optimization in manufacturing processes to enhance production efficiency.
生物工程、化学工程、制药工程、生物技术、生命科学等相关专业本科及以上学历。B
achelor's degree or above in biological engineering, chemical engineering, pharmaceutical engineering, biotechnology, life science or related majors.
至少 10年 在生物制药行业的生产经验，其中至少6年 担任原液生产部门高级管理职务（如高级经理、总监），拥有丰富的团队管理经验；
Over 10 years of production experience in the biopharmaceutical industry, including at least 6 years as senior management position (e.g., senior manager, director) in the bulk production department, with rich team management experience;
深刻理解生物药原液生产的全过程，精通上游和/或下游操作。具备深厚的GMP等法规知识；
Deep understanding of the whole process of biological drug substance, and be proficient in upstream and/or downstream operations. Have a deep knowledge of GMP and other regulations;
拥有领导团队成功通过国内外药品监管机构审计的丰富经验。有成功完成临床后期或商业化项目技术转移和工艺验证的经验；
Extensive experience in leading the team to successfully pass the audit of domestic and foreign drug regulatory agencies. With successful experience in technology transfer and process validation of late-stage clinical or commercialization projects;
卓越的领导力、决策能力和沟通协调能力，能够激励团队并在跨部门合作中有效推动项目；
Excellent leadership, decision-making and communication skills to motivate teams and effectively drive projects across departments;
出色的分析和解决复杂问题的能力，熟悉偏差调查、CAPA、变更控制等质量体系工具；
Excellent ability to analyze and solve complex problems, familiar with quality system tools such as deviation investigation, CAPA, change control;
具备熟练的英语读写能力，英语口语可以作为工作语言。
Fluent in written and spoken English; capable of using English as a working language.
