Drug Substance Development Cell culture Unit Head

Job title: Drug Substance Development Cell culture Unit Head

• Location : Marcy l’etoile, France
• Grade: L3
• Hiring Manager : Corinne BRESSON

About the Team

The vaccines division of Sanofi is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Within Vaccine CMC Development & Supply Function and Global Bioprocess Development Department, the Global Drug Substance team's mission is to develop and scale-up culture and purification processes to support new vaccine development and clinical manufacturing implementation.

Main Responsibilities

Scientific & Project Leadership

• Lead the Drug Substance Development unit, comprising around 10–15 collaborators (with non-perm) — scientists (MSc and PhD) and technicians — covering Upstream (USP) and Downstream (DSP) processes for Cell & Viral projects (eukaryotic)
• Contribute to the definition of New Vaccines project plans, providing high-level scientific expertise and strategic recommendations to project teams
• Represent the unit in expert groups, CMC project teams (as Project Contact Point, Bioprocess Team Member, or DS Team Member), in close liaison with the CMC Leader
• Participate in and/or lead cross-functional working groups with platform partners from GBD North America, Analytical Sciences, Immunology, Antigen Design, and MSAT departments
• Drive the platform's scientific visibility through oral presentations, posters, scientific publications, and patent filings
• Act, as applicable, as DS subteam leader, VITA subdomain leader, and/or GABIE expert

People & Operations Management

• Lead, develop, and inspire a multidisciplinary team, ensuring the skills and knowledge required to deliver on unit objectives
• Develop plans to maintain, improve, and build new competencies; assess resources (personnel, facilities, and equipment) necessary to meet current and future goals
• Improve competencies through training and collaboration with internal or external sources (universities, biotech companies, contract manufacturers, etc.)
• Establish criteria for measurable performance of the team and monitor with KPIs
• Manage unit resources and activities to ensure timely achievement of project milestones and platform objectives
• Prepare, control, and monitor budgets for project and unit activities
• Oversee the maintenance and upkeep of facilities, equipment, and product inventories under the unit's responsibility
• Ensure unit adherence to current regulatory practices and guidelines, safety, biosafety standards, and Good Research practices

Collaboration & Technology Transfer

• Work closely with the Vaccine Drug Substance Development group based in Toronto to accelerate the R&D portfolio and align ways of working
• Foster cross-site and cross-functional collaboration to facilitate knowledge and technology transfer from and to EU units and partner organizations
• Work in close partnership with the Drug Product Development team and GMP/GCS teams to prepare and secure clinical batch production
• Collaborate with external partners including universities, biotech companies, and contract manufacturers
• Ensure the successful transfer of processes, techniques, information, and systems from Vaccine Drug Substance Development units to the VCDS GMP group
• Support and promote team members to actively contribute to VITA networks

About You

Experience

• Engineer or PhD with 15+ years of experience in eukaryotic cell culture, recombinant protein production (CHO or equivalent mammalian systems), and/or viral vaccine development and industrialization
• Experience in drug substance development and/or industrialization strongly preferred
• Understanding of complex R&D landscapes globally; ability to identify cutting-edge technologies and new directions
• Strong academic and biotech/pharma scientific networks
• Proven experience leading multi-disciplinary teams (N ≥ 10)
• Soft Skills
• Team management and cross-functional management
• Excellent interpersonal and oral communication skills
• Leadership and ability to inspire teams

Technical Skills

Cell Culture & Upstream Processing (Eukaryotic)

• Strong expertise in eukaryotic cell culture systems, with a focus on CHO (Chinese Hamster Ovary) cells, insect cells (Sf9), and/or other mammalian cell platforms
• Deep knowledge of recombinant protein production in eukaryotic cells: cell line development, stable transfection, clone selection, media optimization
• Expertise in upstream bioprocessing: bioreactor operations (batch, fed-batch, perfusion), process optimization and scale-up from lab-scale to pilot and commercial manufacturing
• Experience with viral vaccine production platforms (e.g., VLP, viral vectors, inactivated/live attenuated viruses)

Virology

• Knowledge of virology fundamentals relevant to vaccine development
• Experience with viral propagation, titration, and characterization methods
• Understanding of biosafety requirements for viral work (BSL-2/BSL-3)

Downstream Processing

• Knowledge or experience in downstream processing techniques for recombinant proteins and viral antigens: chromatography (affinity, ion exchange, size exclusion), ultrafiltration/diafiltration, viral inactivation/clearance
• Experience in purification process development and optimization

Molecular Biology & Biotechnology

• Expertise in molecular biology relevant to recombinant protein production: gene expression systems, vector design, transfection strategies
• Familiarity with analytical characterization methods for recombinant proteins and viral antigens (SDS-PAGE, Western blot, ELISA, SEC-HPLC, DLS, PCR, sequencing)
• Understanding of cell line engineering approaches for improved protein expression

Digital & Process Technologies

• Knowledge of automation and/or data management systems

Languages

• Fluent professional English

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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!

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.