Job Functions 岗位职责
Organized with strong prioritization and ｅｘｅｃution skills;
有较强的优先级工作处理能力和执行力；
Enjoy working in highly structured system to lead changes that improve operational efficiency and product quality;
能够乐于做一些能够提升工作效率和产品质量的创新；
Good communication skills to peers and external vendors.
能够较好地与公司内部同事与外部供应商进行沟通交流。
Job Functions 工作职责
Job functions include, but are not limited to the following:
工作职责包括但不限于：
Management 管理
Lead and manage the Microbiological team for overall Microbiology activities in compliance with cGMP;
带领和管理微生物团队，确保所有行动都应符合cGMP
Lead and manage the EM team for overall EM activities in compliance with cGMP;
带领和管理EM团队，确保所有行动都应符合cGMP
Promote collaboration and communicate with other functional areas and clients to ensure timely completion of Microbiological and EM activities to meet project timeline;
促进与其他职能部门和客户的合作和沟通，确保微生物和环境控制活动按时完成，以满足项目时间表
Coordinate laboratory activities, improve data and document quality to meet client expectation;
协调实验室活动，改进数据和文件质量以满足客户的期望。
Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs;
制定培训计划。确保所有员工接受基本的cGMP培训、适用的技术和sop培训;
Lead the specification and procurement of equipment, start-up, commissioning and testing of Microbiological Laboratories for clinical and commercial biologic products;
主导临床和商用生物制品微生物实验室的设备规范和采购、启动、调试和测试;
Lead the specification and procurement of equipment, start-up, commissioning and testing of EM Laboratory;
主导环境监测实验室的设备规范和采购、启动、调试和测试;
Lead the technology transfer of Microbiological methods, testing protocols, etc.;
主导微生物方法、测试协议等技术转让;
Provide guidance and oversee method qualification/validation, troubleshooting, laboratory and OOS investigation;
指导和监督方法的确认/验证、故障排除、实验室和OOS调查;
Manage the overall microbiological operations to support cGMP operations;
管理所有微生物操作，支持cGMP行动;
Manage the program of testing encompassing environmental monitoring, testing critical utilities (e.g. WFI, PW, special gases, HVAC), intermediates, and drug products are required;
管理环境监测、关键公用设施(如WFI、PW、特殊气体、HVAC)、中间体、药品等的检测项目;
Provide technical support as the Subject Matter Expert (SME) level for guidance on test methods and procedures.
作为主题事务专家(SME)级别提供技术支持，指导测试方法和程序。
Safety and environment 现场安全和环境合规
Promote a culture of safety work place through personal actions;
以身作则推动建立安全的工作环境；
Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序
Laboratory equipment 实验室仪器设备
Manage and perform and/or support equipment and QC support systems, ensure the lab is in clean status
管理、执行以及/或支持仪器设备和QC辅助系统,确保实验室处于整洁有序的状态
Ensure calibration and maintenance is within expiration date basing before use
确保仪器在使用前其计量和/或维护在有限期内
Initiate and revise related equipment operation procedure
起草和更新相关仪器的操作流程
Testing 检验
Conduct compendial method , Microbiology and EM testing;
执行药典常规方法、微生物和环境测试
Be familiar with basic testing methods of Microbiology and meidia & culture management
熟悉相关微生物基本检测方法和培养基&菌株的管理
Initiator and review methods and procedures for completeness and accuracy;
起草方法操作规程和其他管理规程，审核其完整性和准确性；
Good time management skills to ensure smooth implementation of projects.
具有很好时间管理能力，以确保项目的顺利实施。
Material/Data Management 物料/数据管理
Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;
对记录、计算、编辑、解释、审核以及录入数据负责；
According to different pharmacopeia, do gap assessment for test；
依据不同的药典，对方法进行差距分析；
Responsible for the inventory management of all test kit and media used in QC testing;
对于所有用于检验的试剂盒和培养基的储存管理负责；
Ensure the timely disposal of tested samples and archive of retention samples;
确保及时处理检验样品和样品的留样
Quality Assurance 质量要求
Comply with the Company Quality Management Systems;
遵守公司质量管理体系;
Initiate new and revise documents, participate in investigation teams, and provide input to quality systems (change control, CAPA, and deviations);
起草新文件和修订文件，参与调查团队并且在质量体系运营中（变更、CAPA和偏差）提供支持；
Comply with GLP and cGMP, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory logbooks.
遵守GLP和cGMP的要求，包括但不限于：培训记录、实验室记录、书面规程、仪器设备监控系统和实验室工作日志的维护。
General 常规要求
Comply with general Company Policies and Procedures
遵守公司政策和程序；
Assist superior to complete other work if needed.
如需要协助上级完成其他相关工作
Qualifications 学历
Priority BS degree in Biochemistry, Microbiology, Immunology, Molecular/cell biology or a related discipline
生物化学、微生物学、免疫学、分子/细胞生物或其他相关领域学士学位优先
Essential Experience 任职资格
Minimum 5 years of QC relevant experience in Anti-body/Bio-pharmaceutical/Vaccine industry;
至少5年抗体、生物制药或疫苗等相关行业QC相关工作经验
Knowledge of standard requirements for plant facility monitoring and basic biological testing as stated by GB, CP, USP, EP, cGMP;
具有国标、中国药典、美国药典、欧洲药典和cGMP等法规关于生物药品检测知识
Working knowledge and hands-on test experience in relevant industry
有相关工业领域工作知识和检测实操经验
Working knowledge and hands-on
Ability to analyze data, troubleshoot
具有数据分析、异常结果原因分析的能力，
Ability to be trained and work closely with other function
具有被培训和能够与其他部门同事共同合作的能力
Excellent communication skills (both verbal and written) and interpersonal skills are required.
较好的沟通能力（口语和写作）以及人际交往能力。
Excellent structured organization skills to meet tight deadline.
优秀的组织能力，能够在截止时间前完成相应工作。
Preferred Experience 优先考虑
Adequate understanding of ICH Quality guiｄｅｌines, including: stability program, quality of biotechnological products, pharmaceutical quality management, and quality risk management;
熟悉ICH质量指南，包括：稳定性程序，生物技术产品的质量，制药质量管理以及风险管理；
Expert knowledge of Good Manufacturing Practice of China, EU, and USA related to Quality Management Systems and Quality Control;
熟悉中国cGMP，欧盟cGMP以及美国的相关质量管理体系和质量控制法规；
Sound understanding of differences between pharmacopeia of China, USA, and EU related to biological products and critical utilities;
熟悉中国药典、美国药典和欧盟药典的区别，以及其中生物制品和关键公用设施的内容；
Thorough understanding of Mab development, manufacturing, and analytical process.
熟悉单抗的开发、生产和分析；

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