Key Expert MSAT USP (all genders) - limited 2 years

Sanofi Group; Frankfurt; On-site; EUR 86,000 - 128,000; Full time

Job summary

Sanofi in Frankfurt (Germany) and Beijing (China) seeks a Key Expert MSAT Upstream Processing to lead development, optimization and tech transfers of upstream bioprocesses for insulin biomanufacturing.

You will drive fermentation and separation steps, scale‑up, DoE, PAT and regulatory submissions, collaborating across global teams to deliver robust processes and compliant product for an international insulin facility.

Qualifications

• PhD or Master’s in Biology/Biotechnology or related field with hands-on upstream processing experience.
• Hands-on experience in fermentation, microbial cultivation, bioreactor operation, media development and process scale-up.
• Familiarity with DoE, PAT and cGMP environments.

Responsibilities

• Implement and optimize upstream processes including fermentation, microbial cultivation, media preparation, and cell banking in laboratory settings for production facilities as part of interdisciplinary teams.
• Optimization of separator technologies, centrifugation processes, and product recovery.
• Drive scale-up activities, process characterization, troubleshooting, and manufacturing start-up operations.
• Participate in technology transfer activities for upstream processes between different manufacturing sites and generate process transfer documentation.
• Develop regulatory submission documents and support process validations across global facilities.
• Establish and equip laboratory infrastructure and capabilities for upstream process development.
• Provide technical input to regulatory dossiers and respond to authority questions regarding upstream processing.
• Represent upstream processing activities in audits and inspections.
• Act as the primary MSAT technical liaison, ensuring seamless sharing of expertise across the global teams.

Skills

DoE

Process modeling

cGMP experience

Analytical chemistry

Education

PhD or Master’s in Biology/Biotechnology

Tools

HPLC

Enzyme assays

Gel electrophoresis

Bioreactor operation

Job description

About the job As Key Expert MSAT Upstream Processing (USP) within our MSAT Recombinant Drug Substance Microbial team, you'll develop, optimize, and transfer upstream bioprocesses for biotechnological manufacturing of peptides and proteins, specifically for our new insulin facility in Beijing.

Ready to get started? Sanofi has decided to invest into new large state‑of‑the art facilities for the full portfolio for insulin drug substances to ensure future oriented, sustainable, reliable and leading‑edge long‑term supply for world‑wide diabetes patients.

The new facilities will be designed as a fully automated, green, modern and state‑of‑the‑art biologics facility considering specific process requirements of all insulins.

The localization of those facilities will be in Frankfurt, Germany and Beijing, China.

You'll be part of a global MSAT Recombinant Drug Substance Microbial team spanning Germany and China, working on cutting‑edge upstream bioprocessing for our transformative Beijing insulin facility project.

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale.

In Manufacturing & Supply, you'll help reimagine how life‑changing treatments reach people everywhere, faster, while driving innovation in biotechnological manufacturing across cultures and continents.

Main responsibilities:

• Implement and optimize upstream processes including fermentation, microbial cultivation, media preparation, and cell banking in laboratory settings for production facilities as part of interdisciplinary teams
• Optimization of separator technologies, centrifugation processes, and product recovery
• Drive scale‑up activities, process characterization, troubleshooting, and manufacturing start‑up operations
• Participate in technology transfer activities for upstream processes between different manufacturing sites and generate process transfer documentation
• Develop regulatory submission documents and support process validations across global facilities
• Establish and equip laboratory infrastructure and capabilities for upstream process development
• Provide technical input to regulatory dossiers and respond to authority questions regarding upstream processing
• Represent upstream processing activities in audits and inspections
• Act as the primary MSAT technical liaison, ensuring seamless sharing of expertise across the global teams.

About you

Education/Experience: PhD or Master's degree in Biology, Biotechnology, Biochemistry, Bioprocess Engineering, Chemical Engineering, or related field; relevant hands‑on laboratory experience in upstream processing including fermentation, microbial cultivation, bioreactor operation, media development, and process scale‑up, knowledge in separator operation, enzyme kinetics and protein folding beneficial

Soft and technical skills:

• Experience with cGMP environments, Design of Experiments (DoE), process modeling, PAT (Process Analytical Technology), and advanced process control systems; Analytics expertise: HPLC, enzyme assays, gel electrophoresis, and microbiological analytical methods; Strong scientific skills with ability to work across cultures and bridge technical, manufacturing, engineering, quality, and regulatory requirements

Languages/additional:

• Fluency in English and German (verbal and written); Chinese language skills advantageous; Willingness to travel to China, to support cross‑cultural collaboration and on‑site implementation activities

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.

Salary and benefits:

• The salary range for this position is :€85.572,00 - €128.340,00
• Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.
• Employees may be eligible to participate in Company employee benefit programs.