Director of Production

Responsibilities

• Be responsible for the cGMP operations of biologics manufacturing facilities including upstream cell culture antibody production, downstream protein purification, fill-finish and supply chain management.
• Provides support in biologics cGMP facility development from design, construction, validation to start-up.
• Establishes and optimizes manufacturing policies and cGMP document systems including standard operating procedures and manufacturing batch records.
• Leads manufacturing process trend analysis and prepares reports using advanced statistical tools for continuous improvement of manufacturing and its process.
• Manages strictly the production system and activities according to the US, EU, Chinese GMPs, leads the subordinates and all of the manufacturing staff to strictly carry out the related work accordingly.
• Checks the production system, quality system and improve the scheme of technical system and equipment maintenance system.
• Evaluates and controls the cost of production, quality, process, and capacity; Develops and controls department budgets.
• Ensures the EHS in manufacturing facilities.
• Be responsible for the planning department head count and managing performance; leading, managing, training and checking day-to-day activities of the manufacturing.
• Prepares the readiness for regulatory inspections on the cGMP facility and biologics manufacturing process.
• Any other ad hoc tasks assigned by line manager.

Qualifications

• Educated to bachelor, master degree level or equivalent, preferably in a related major in biochemical engineering, biotechnology, and biological sciences
• Minimum 8 years related experiences of manufacturing in a global biopharmaceutical company; and minimum 5 years experience at the managerial level or above
• Familiar with Biotech industry and monoclonal antibody drug manufacturing
• Have in-depth knowledge and hands-on experiences with US, EU and Chinese GMPs regulatory and quality standards requirements for biologics manufacturing
• Understanding of business objectives and the impact of operations and technical activities on those objectives
• Rich experiences in production management, equipment management, quality management and a regulatory inspection of biologics are highly preferred
• Excellent verbal and written communication skills in both Chinese and English
• Result-oriented approach
• Excellent organizing ability, communication and interpersonal skills at all levels
• Strong influencing skills
• Strong analytical/problem-solving skills
• Ability to lead groups including subordinate, peer, and site leadership

工作职責

• 负责生物药cGMP生产运营的操作，包括上游细胞培养，抗体生产，下游蛋白质纯化，制剂以及供应链管理。
• 支持生物药cGMP工厂建设，从设计，施工，验证到启动生产。
• 建立完善各类生产需要的政策制度，cGMP标准文档系统包括日常操作流程以及生产批记录。
• 领导建立生产过程中的趋势分析，并用先进的统计学等工具准备相关报告以对生产和生产工艺进行持续改进。
• 严格按照美国，欧盟，中国GMP法规对工厂生产体系和生产活动等进行管理，组织领导下属及员工严格执行相关工作标准。
• 审核生产体系，质量体系，技术体系改善方案以及生产设备维护方案。
• 负责生产成本，质量，过程，产能的评估和控制；准备和控制部门预算。
• 负责保证工厂的安全,健康和环境生产。
• 负责工厂人员结构规划、人员配置管理，并负责对部门人员及工作的日常管理、培训，监督检查，做好部门考核工作。
• 迅速响应及准备关于cGMP工厂设施和生物药生产工艺的相关监督检查；
• 领导交代的其他任务。

任职条件

• 本科或硕士以上生化工程，生物技术或生物科学相关专业学历
• 8年以上大型跨国生物制药企业生产相关经验以及至少5年以上管理经验
• 熟悉生物科技行业以及单抗药物生产
• 熟悉美国，欧盟，中国的GMP对于生物药生产的规范和质量标准要求
• 能够完全理解经营目标并且配合目标设定相应的生产目标
• 在生物药的生产管理，设备管理，质量管理，监督检查有丰富经验者优先
• 优秀的中英文书面和口语表达能力
• 优秀的组织，沟通和人际关系协调能力
• 优秀的影响力和领导力
• 优秀的分析和解决问题的能力