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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 Head of IFB Operations 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. This position 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 and ensuring compliance with local regulations.

Key Responsibilities

China-Specific Operational Strategy and Project Leadership

• Develop and implement a future-oriented, highly efficient operational concept 

• Implement training concepts to local Chinese operational workforce
• Drive culture of continuous innovation and technological advancement.

Engineering Partnership

• Partner closely with engineering functions to ensure operational expertise is integrated throughout the program.
• Establish and deliver user requirements for insulin products specific to the Chinese market and manufacturing unit.

Digitalization

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

Regulatory Compliance and Stakeholder Management

• Ensure seamless implementation of biologics manufacturing processes, cGMP requirements, and quality standards that meet both international and Chinese regulatory expectations
• Lead and contribute to authority interactions and submissions related to the China site
• Collaborate with local stakeholders

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 international regulatory requirements for biologics manufacturing
• Technical expertise in biotech upstream and/or downstream manufacturing of biologics
• 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
• 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.

This position offers an exciting opportunity to lead a critical project for Sanofi in the rapidly growing Chinese pharmaceutical market. The successful candidate will play a pivotal role in establishing Sanofi's presence in insulin manufacturing within China, contributing to the company's global mission while addressing the specific needs of the Chinese market.