M&S-IFB-Contamination Control Manager

About the job

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. 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.

Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!

Main responsibilities:

• Provide quality leadership for Contamination Control throughout all phases of the IFB project, from design to validation and final approval. This includes but is not limited to: Bioburden control, filter concept, cleaning and disinfection, gowning, environmental controls and product protections e.g. process closure.

• Develop and implement Contamination Control concepts and decisions at project level.

• Represent the project on contamination control matters and ensure compliance with Sanofi standards, contamination control regulations and requirements.

• Responsibility for the Contamination Control Strategy for IFB

• Close collaboration with Micro Quality control lab, other Quality functions as well as Production and Engineering.

• Ensures regular reporting to the Global Contamination Control and Micro Quality Control Project Lead InsuLINK.

• Interacts with the Frankfurt facility to keep benchmark and best practices cross-fertilization.

• Support the optimization of manufacturing costs, efficient resource use, and streamlined operations and maintenance.

• Focus on energy efficiency, waste reduction, digitalization, and alignment with Sanofi's sustainability goals.

About you

• Education/Experience: MSc or PhD degree or equivalent in natural sciences, ideally Microbiology; experience in Leadership positions with a proven track record of delivery and compliance; significant industry experience, preferably within the Microbiology Quality Control or Sterility Assurance position at an industrial site; In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.

• Soft and technical skills: Leadership and assertiveness skills, knowledge of Quality systems, GxP and regulations, Quality Risk Management, Continuous improvement management, experience with Chinese authorities and international and FDA exposure

• Languages: proficiency in Chinese and English required

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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.

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