M&S - IFB - USP Operation Expert
About this opportunity
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
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
Job details
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We currently track 1527 comparable Manufacturing & CMC roles across 125 biopharma companies.
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