原液生产总监

南通，中国   |   全职   |   Job ID: 11655 

About the role:

Your contribution:

• 全面负责原液生产车间（细胞培养、下游纯化）的日常运营和生产执行，确保按时、按质、按量完成生产目标；
  ​Take overall responsibility for the daily operation and production execution of the raw liquid production workshop (cell culture, downstream purification), and ensure that the production goals are completed on time, with good quality and in good quantity;
• ​监督并审核生产批记录、SOP、生产技术报告等关键文件，确保所有操作有据可循，数据完整可靠；
  ​Supervise and review key documents such as production batch records, SOP and production technical reports to ensure that all operations are based on evidence and the data is complete and reliable;
• ​主导解决生产过程中出现的复杂技术问题、偏差调查、纠正与预防措施（CAPA）的实施，确保根本原因得到有效分析并解决；
  ​Lead the solution of complex technical problems in the production process, deviation investigation, and the implementation of corrective and preventive measures (CAPA), to ensure that the root cause is effectively analyzed and solved;
• ​作为生产部门代表，全力支持各类审计，并确保所有审计发现项得到及时有效的整改；
  ​As a representative of the production department, fully support all kinds of audits and ensure that all audit findings are rectified in a timely and effective manner;
• ​确保生产活动始终符合cGMP、EHS以及所有相关的法律法规要求；
  ​Ensure that production activities are in compliance with cGMP, EHS and all relevant legal and regulatory requirements;
• ​与质量保证、质量控制、工艺开发等部门紧密合作，共同维护高质量体系；
  ​Work closely with QA, QC, PD and other departments to maintain a high-quality system;
• ​负责团队成员的招聘、培训、绩效评估和职业发展规划；
  ​Responsible for team member recruitment, training, performance evaluation and career development planning;
• ​负责编制和管理原液生产部门的年度预算，有效控制生产成本和费用；
  ​Responsible for the preparation and management of the annual budget of the raw liquid production department, and effectively control the production costs and expenses;
• ​负责生产设备、耗材和物料的规划与管理，确保生产资源的充足和高效利用。
  ​Responsible for the planning and management of production equipment, consumables and materials to ensure sufficient and efficient use of production resources.​ 

A good match:

• ​​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.​