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