南平招聘

-Contribute to develop the function “Analytics Expert Center and House of ChP” at the Beijing Pharma Injectables site
-Manage the overall activities of “Analytics Expert Center and House of ChP” at the Beijing Pharma Injectables site to ensure technical guidances and training are available and adequate to perform day to day tasks, and ensure the methods, equipment, systems and workflows are fit for purpose, up to date and efficient
-Contribute to build and maintain high level pro-active technical communication on SANOFI’s biological product specifications and test methods with NIFDC or other relevant authority drug control institutes
-Perform internal analytical testing of the diverse portfolio of imported SANOFI biological products to verify results and ensure successful analytical testing by the authorities labs within agreed timelines
-Coordinate detailed planning and closely follow up for proper and timely supply of materials and analytical procedures required for product testing to the authorities lab utilizing available on-site storage capacity
-Lead assigned projects to provide appropriate and timely answers to questions from the NIFDC or any other authority institute with respect to analytical methods and product specifications and provide analytical method trouble shooting support when required
-Provide timely response to NIFDC or any other authority institute and defend SANOFIs position when they request changes to analytical procedures and / or specifications. If required consult with sending unit for the appropriate response
-Coordinate and liaise with cross-functional units and stakeholders on planning, resourcing, execution and reporting of analytical method comparison and equivalence studies, if required
-Liase with CMC development team, sending unit and global as well as local Pharmacopeia expert groups to ensure that compendial methods for newly submitted products comply with ChP
-Work transversally and collaboratively with SANOFIs Biologics QC analytical Hubs and expert network to build and maintain state of the art training status, knowledge and capabilities
-Work transversally and collaboratively with all other relevant stakeholders incl. local and global Quality and Regulatory functions, global Analytical functions , iCMC-NPP and other relevant R&D functions to ensure successful registration and to achieve fast registration and launch timelines for SANOFIs investigational and commercial products
-Provide regular project updates and escalate key issues and risks incl. a risk mitigation plan to next level management when appropriate
-Identify gaps in the knowledge base and make recommendations for improvement of current processes to state of the art ways of working
-Optimize collaboration and integrate the perspectives with other functions and external stakeholders to improve efficiency of cross-functional processes, projects, etc.
-Understand business and financial impacts of the analytical and Pharmacopeia work, strategically, tactically and from a broad, conceptual perspective
-Contribute to the development of a global network of analytical experts across SANOFI to ensure use of state of the art processes and analytical procedures
-Provide analytical expertise to support local projects
-Support due diligences
-REQUIREMENTS &
职位要求：
Qualifications:
Basic Qualifications (Education / Experience)
-At least a bachelor or above degree in biotechnology, biochemistry, analytical chemistry, chemistry, biology or pharmacy or other equivalent scientific discipline
-Minimum of 5 years working experience in pharmaceutical or biotech industry, preferably in an analytics environment
-Minimum of 3 years project / management experience
-Excellent oral and written communication skills, fluent in Mandarin Chinese and English, verbally as well as in writing
-Specific Qualifications
-Professional experience preferably in the area of analytical development, analytical process sciences？ quality control or protein analytics
-Proven hands-on experience in analytical methodologies for several biological molecule classes such as mAbs, recombinant and natural proteins, enzymes, cells, plasmids, etc.
-Proven experience with protein and antibody assays such as H/UPLC, capillary electrophoresis, SEC, CE-SDS, icIEF , oligosaccharide analyses and cell-based bioassay
-Strong working knowledge of physicochemical, bioanalytical and general methods used for biological products
-In-depth knowledge of local and global pharmaceutical /GxP regulations, ICH guidelines, relevant Pharmacopeias (ChP, JP, EP and USP) and best practices for analytical testing laboratories
-Project management skills and experience to work in interdisciplinary project teams
-Broad scientific background and excellent presentations skills
-Ability to work in high paced team environment, meet deadlines and prioritize work from multiple projects
-A good working knowledge of MS Office applications
-Experience with assay transfers for biological products, quality management systems, statistical analysis and lean methodology are a plus
-Core Competencies Behavioral qualifications
-Strong communication skills to operate in a cross-functional and international environment
-Pronounced ability to cooperate transversally throughout the organizations and with external partners
-Competence to work in a team environment, facilitate a team approach and communicate effectively
-Ability to take decisions within teams and assure timely reporting or escalation to next level management
-Capability to understand, learn and leverage from the diverse backgrounds and experiences
-Strategic mindset, understanding of the “big picture”, business oriented, and responsive decision making
-Strong negotiation, communication as well as conflict management skills across different cultures
-Proven track record in working with both China and Western cultures
-Act for change within project matrix, develop efficient ways of working to drive project results
-Good level of self-organization, analytical and structured way of thinking, a high sense of responsibility and decisiveness
-Excellent interpersonal and influential skills
-Agree to travel (up to 30%)
在赛诺菲，多样性和包容性是我们如何运作和嵌入核心价值观的基础。我们认识到，要真正挖掘多样性所带来的丰富多彩，我们必须以包容为先导，并拥有一个工作场所，在那里，这些差异可以茁壮成长，并被利用起来，让我们的同事、患者和客户的生活更丰富多彩。我们尊重和颂扬我国人民的多样性、他们的背景和经验，并为所有人提供平等的机会。

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
 全球100,000余名员工，业务遍及100个国家
 新兴市场实力均衡，表现强劲，位列***
 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
 疫苗领域的领导者
 领先动物保健市场
 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
   
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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