Job title职位名称: Scientist - Analytics Expert Center and House of ChP

• Location工作地点： Beijing

About the job工作职责

Our Team我们的团队：

Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.

制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。

Main responsibilities职责描述：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

• This position is put in place as part of the global China 2030 roadmap to support launch of SANOFI’s rich biologics product portfolio in China which represents an important business opportunity for the company and to design the future of SANOFI’s biotech capabilities in China together with other stakeholders. This position has responsibility to build and maintain high level technical communication with China health authority labs and to support both registration and importation testing of SANOFI’s Biological products launched or to be launched in China. This includes provision of detailed method descriptions, timely answers to questions with respect to methods and specifications as well as required trouble shooting support to ensure successful testing and to achieve fast registration and launch timelines for investigational and commercial products, respectively. In addition, this role provides technical consultation to ensure that SANOFIs products comply with Chinese Pharmacopeia (ChP). This role will require laboratory work as well as the generation of technical reports.
• Lead assigned projects and work transversally and collaboratively with all other relevant stakeholders incl. local and global Quality and Regulatory functions, global Analytical functions, CMC PM, China Launch Excellence and other relevant R&D functions to ensure successful registration and to achieve fast registration and launch timelines for SANOFIs investigational and commercial products including
  • Establish and evaluate critical methods in AEC and support testing material readiness and method transfer in agency labs
  • Work collaboratively with regulatory teams, manufacture sites and other stake holders to support preparation of China registration specification of biological products to achieve submission on aligned timeline. 
  • Provide appropriate and timely answers to questions from authority institute with respect to analytical methods and product specifications and provide analytical method trouble shooting support when required
• Provide analytical technical support on lifecycle management and importation testing of already launched biological products to secure commercial supply.
• Contribute to build and maintain high level pro-active technical communication on SANOFI’s biological product specifications and test methods with authority drug control institutes
• Work transversally and collaboratively with SANOFIs Biologics global QC, MSAT and R&D teams and expert network to build and maintain state of the art training status, knowledge and capabilities. Lead or support local technical colleborations if required.
• Coordinate and liaise with cross-functional units and stakeholders on planning, resourcing, execution and reporting of analytical method comparison and equivalence studies, if required.
• 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.
• 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.
• Provide analytical expertise to support local projects

About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

• Experience:

工作经验:

• Minimum of 5 years working experience in pharmaceutical or biotech industry, preferably in an analytics environment

• Soft skill:

通用技能:

• Strong communication and influence skills in a cross-functional and international environment.
• Project management skills.
• Ability to work in high paced team environment, meet deadlines and prioritize work from multiple projects
• Ability to take decisions within teams and assure timely reporting or escalation to next level management
• 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
• Good level of self-organization, analytical and structured way of thinking, a high sense of responsibility and decisiveness

• Technical skill:

专业技能:

• Strong technical innovation and trouble-shooting skills in cell biology, molecular biology and biochemical research.
• Knowledge with cellular models of diseases, protein interaction, immunoassay, flow cytometry, cell signal transduction, immune regulation and mammalian cell culture.
• Experience in lab management to ensure daily operation.
• In-depth understanding analytical method lifecycle management for biologics and general manufacture process for biologics.
• Extensive working knowledge and hands on experience of physicochemical, bioanalytical and general methods used for biological products.
• Knowledge of local and global pharmaceutical /GxP regulations, ICH guidelines, relevant Pharmacopeias (ChP, EP and USP) and best practices for analytical testing laboratories.
• Broad scientific background and good presentations skills.

• Education:

教育背景:

At least master or above degree in Biochemistry / Biotechnology, Cell Biology, Immunology or related field.

• Languages:

语言要求:

Good oral and written communication skills, fluent in Mandarin Chinese and English, verbally as well as in writing

• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。