上游生产主管 USP Leader-河北

管理日常上游生产活动，确保满足生产计划顺利完成。 Supervise daily upstream production activities to ensure successful completion of the production plan. 与工艺开发和项目管理小组合作进行技术转让和工艺验证。 Collaborate with Process Development and Project Management groups for technology transfer and Process Validation. 提供细胞培养操作方面的工作知识和技术领导。 Provide working knowledge and technical leadership in cell culture operations. 与QC和QA小组合作，确保GMP合规，管理偏差调查、变更撰写和CAPA实施，并支持客户审计和机构检查。 Works with QC and QA groups to ensure GMP compliance, manage deviation investigations, change writing and CAPA implementation, and support customer audits and facility inspections. 协助生产主管协调上游组和其他职能组之间的工作，按照计划达成生产目标。 Assists manufacturing supervisors in coordinating work between upstream and other functional groups to achieve production goals as planned. 负责创新文化和持续改进。主动领导变更能够提高一次正确率，生产效率和成本减少。 Responsible for innovative culture and continuous improvement. Active leadership changes can improve the accuracy rate, production efficiency and cost reduction. 及时向领导反馈工艺、人员、安全及其他事务的问题和运作状况，必要时能给予详述。 Provide timely feedback to leaders on process, personnel, safety and other matters and operational status, and provide detailed description if necessary. 领导团队建设，不断提高团队整体能力，使团队绩效得到有效管理。 Lead team building, continuously improve the overall team capacity, so that team performance can be effectively managed.

本科及以上药学、化工、生物、生物化学及其他相关专业。 Bachelor degree or above in pharmacy, chemical industry, biology, biochemistry and other related specialties. 至少5年在cGMP生物制造环境中工作，具有管理下属和/或领导项目团队的经验。熟悉上游细胞培养、发酵工艺。 Worked in cGMP biomanufacturing environment for at least 5 years with experience in managing subordinates and/or leading project teams. Familiar with upstream cell culture and fermentation process. 良好的英语口语和写作能力；有6西格玛及5S管理经验者优先。 Good spoken and written English; 6 sigma and 5S experience preferred. 能面对生产工作环境的日常挑战，同时具备积极的工作态度，并能将积极的态度传播给下属。 Be able to face the daily challenges of the production work environment, while having a positive attitude to work, and can spread a positive attitude to subordinates. 具有良好的沟通能力、理解能力和团队管理能力。 Have good communication ability, understanding ability and team management ability.