職位描述
-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 &
職位要求：
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%)
在賽諾菲，多樣性和包容性是我們如何運作和嵌入核心價值觀的基礎。我們認識到，要真正挖掘多樣性所帶來的豐富多彩，我們必須以包容為先導，并擁有一個工作場所，在那里，這些差異可以茁壯成長，并被利用起來，讓我們的同事、患者和客戶的生活更豐富多彩。我們尊重和頌揚我國人民的多樣性、他們的背景和經驗，并為所有人提供平等的機會。
