Job title: Head of IFB (Insulin Facility Beijing) Operations

Location : China

Background

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. The new facility will be designed as a fully automated, green, modern and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing. One important role of this program organization is the IFB (Insulin Facility Beijing) Operations Head reporting to the Global Operations Head of the new insulin facilities program. 

About the Role

The IFB Operations Project Head will play a crucial role in partnering engineering during the project and in developing, establishing and managing Sanofi's new insulin manufacturing facility in China. This position requires a strategic thinker with strong project and operational expertise in biologics manufacturing, particularly in the Chinese market.

Key addition: This position will be a legal representative for the new site and will be a critical interface to external regulatory and government bodies. The IFB Operations Head will represent both the project and Sanofi in official capacities. This role involves building and maintaining relationships with Chinese authorities, effectively communicating project progress, ensuring compliance with local regulations, and advocating for the company's interests in the Chinese pharmaceutical landscape.

Key Responsibilities

1.China-Specific Operational Strategy

Develop and implement a future-oriented, highly efficient operational concept Design an organizational structure that aligns with Chinese business practices and regulatory requirements.Implement training concepts to local Chinese operational workforce, considering cultural nuances and educational backgrounds.

2.Engineering Partnership

Partner closely with engineering functions to ensure operational expertise is integrated throughout the program.Collaborate with engineering teams to align design and implementation of facilities and equipment with operational needs and future requirements.Provide operational insights and requirements to inform engineering decisions, ensuring that all engineering activities are well-suited to long-term operational needs.

3.Operational Leadership and Innovation

Lead and oversee all operational activities within the IFB facility, driving a culture of continuous innovation and technological advancement.Develop and implement pioneering operational concepts specific to the IFB

4.Project Leadership

Lead all operational activities within the program for the China site, from inception to commercial readiness.Establish and deliver user requirements for insulin products specific to the Chinese market and manufacturing unit.Ensure seamless implementation of biologics manufacturing processes, cGMP requirements, and quality standards that meet both international and Chinese regulatory expectations.

5.Digitalization

Implement sustainable concepts based on global digital directionsSpearhead the design of operational processes based on fully digitalized systems, aligning with China's rapid technological advancements and digital transformation initiatives.

6.Regulatory Compliance and Stakeholder Management

Lead and contribute to authority interactions and submissions related to the China siteCollaborate with local stakeholdersEnsure compliance to FDA and EMEA regulations in addition to China regulations

Qualifications

Master's degree or PhD in Chemical Engineering, Biotechnology, Bioengineering, or related field from a reputable institution (Chinese or international).10+ years of experience in Biologics DS manufacturing, with significant exposure to the Chinese pharmaceutical industry.Proven experience in cGMP operations & project execution within the Chinese regulatory framework.In-depth knowledge of Chinese cGMP and regulatory requirements for biologics manufacturing.Technical expertise in biotech upstream and/or downstream manufacturing, with an understanding of how these processes may need to be adapted for the Chinese market.Experience with automation, PAT technology, and online analytics, particularly in the context of Chinese manufacturing practices.Demonstrated ability to build and lead high-performing teams in a Chinese cultural context.Strong skills in organization design, change management, talent management, and strategic workforce planning, with an emphasis on Chinese labor practices and cultural norms.Excellent leadership, communication, and teamwork skills, with the ability to navigate complex cross-cultural environments.Extensive intercultural experience, especially within China and between China and global teams.Fluency in English and Mandarin Chinese (both written and spoken) is required.

Further Preferred Qualifications

Experience working with Chinese government bodies and regulatory agencies in the pharmaceutical sector.Knowledge of local Chinese business practices, etiquette, and networking (guanxi).Familiarity with Chinese labor laws and HR practices in the pharmaceutical industry.

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