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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Scientist - Analytics Expert Center and House of ChP within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

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
• Support due diligences

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
• Oversea training or experience

• 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.
• In-depth 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.
• Strong Willingness for hand-on experiment.
• In-depth understanding analytical method lifecycle management for biologics and general manufacture process for biologics.
• Strong working knowledge and hands on experience 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, EP and USP) and best practices for analytical testing laboratories.
• Broad scientific background and excellent 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:

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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!