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:

• Lead the Microbiology Quality Control lab team by providing appropriate training, mentoring, review and development to ensure retention of talented people and robust succession planning across key positions.

• Provide leadership, strategic guidance and recommend policies, procedures, and activities ensuring robust microbiology quality control is in place.

• Responsible for the delivery of micro quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality

• Manage micro quality control lab team consisting of internal and external experts.

• Ensure the project and specifically the microbiology lab performs according to the Sanofi Standards and best practice.

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

• Responsible for microbiology quality control laboratory operations, test method approvals, and method validation processes as well as transfer of methods from Frankfurt Biocampus Germany.

• Oversee lab readiness to perform the needed activities in the project phases.

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 including Annex 1 knowledge in production and development of active substances and drug product (e.g. Steriles, Vaccines and Biotechnology)

• 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