M&S - IFB - USP Operation Expert

Background  

Sanofi has decided to invest in new, state-of-the-art production facilities for the entire insulin portfolio as part of the InsuLINK program, to ensure a future-oriented, sustainable, and reliable long-term supply for diabetes patients worldwide.  

Beijing, China (IFB = Insulin Facility Beijing) and Frankfurt, Germany (IFF = Insulin Facility Frankfurt) have been selected as the locations for the two facilities.  

The new production facilities will be designed as fully automated, environmentally friendly, and state-of-the-art biologics facilities that consider the specific process requirements of all insulins.  

Position Overview  

We are looking for 4 Operation Experts for the workstreams "Upstream" and "Downstream" for the following focus areas:  

- USP: Upstream / Fermentation  

- MSP: Midstream / Cell harvest to Bag filter  

- DSP: Downstream I / High Purification, Chromatography  

- DSP: Downstream II / Isolation and Drying  

They will report to the respective department heads of USP, MSP, DSP I and DSP II.  

These positions play a crucial role in the design, planning, construction, and commissioning of our new state-of-the-art insulin production facility in Beijing, as well as the product transfer into routine production.  

The successful candidates will work within the Operations unit in close partnership with the Engineering teams to help shape the success of this project.  

Responsibilities  

Represents the know-how and operational knowledge of their workstreams within the project team  

Supports the project tasks of their teams in various phases of the engineering/construction project, e.g., planning and design, P&ID review, HAZOP, functional design, author the URS and lead the technical clarification with Frankfurt.  

Partnership and collaboration with Engineering on various project topics:  

Creation of process-relevant and clean utilities user requirements  

Equipment and system designs  

Development of Standard Operating Procedures (SOPs) and operational documentation  

Commissioning of equipment and systems  

Lead to ensure technical design is fulfilled and consistent with IFF.  

Coordinate within responsible steps for digital solution implementation, such as MES, DCS etc.  

Ensure in OQ/PQ/PPQ execution for the manufacture of insulin  

Partnership with MSAT in technology transfer and scale-up activities, efficient collaboration in highly cross-functional teams  

About You  

Experience  

Bachelor’s degree in chemical engineering, Biotechnology, Bioengineering, or a related field  

Alternatively, qualification as a Technician/Master Craftsman with many years of experience in a production environment in pharmaceutical manufacturing  

More than 2 years of industrial experience in the pharmaceutical environment with a strong focus on the manufacture of insulins, biologics or other pharmaceutical substances   

cGMP knowledge  

Technical background in insulin manufacturing is a plus  

Skills  

Ability to work under high pressure in a constantly changing project environment  

Ability to work in a highly matrix-driven project environment with strong functional reporting lines  

Leadership skills for both functional and directly reporting teams  

Excellent teamwork and communication skills  

Ability to collaborate closely and build cross-functional bridges  

Willingness to travel to Germany for knowledge transfer  

English language skills in both speaking and writing