Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

OUR TEAM

Within the R&D Global CMC Development organization, the Biologics Formulation and Process Development team is responsible for developing safe, stable, and patient-centric biologic Drug Products and associated manufacturing processes. Our scope of work extends from early development candidate selection through clinical stages, product launch & life-cycle management. The team integrates multiple scientific expertise such as protein stabilization, biochemistry, physical-chemistry and pharmaceutical engineering, and interacts with diverse partners from research, clinical development or industrial affairs.

What you have to know about this opportunity

• Job title: Drug Product Development Scientist of Biologics
• Location: Vitry Sur Seine
• Maximum 40 % remote working, occasional travel expected
• Permanent, full-time job

Main responsibilities

Summary: Within the R&D CMC development department, the Drug Product (DP) Development Scientist is responsible for the development of the DP of therapeutic proteins, such as monoclonal antibodies, antibody-drug conjugates, fusion proteins, multispecific mAb scaffolds, etc. He/she will contribute to different development steps, such as formulation selection, container closure and device compatibility, preparation of fill & finish batch manufacturing, preparation of in-use compatibility studies, drug product process development and transfer to GMP and Industrial Affairs manufacturing sites. The responsibilities of the DP development scientist start at the final step of purification of the therapeutic protein and extend all the way to the administration of the drug to the patient.

• Design and supervise the execution of formulation development, compatibility with administration systems, formulation robustness and other types of studies throughout the product development cycle. He/she may also perform lab-bench activities
• Write and review electronic lab notebooks, experimental protocols, quality documents, experimental and analytical methods, scientific reports and other technical assessments
• Communicate results and experimental data to internal stakeholders and government bodies
• Take the role of Drug Product Team Leader for 1 or more projects throughout the different product development phases (1-3). This role involves the coordination of formulation development, process development and manufacturing activities across the Drug Product Development organization, as well as the participation in interdisciplinary teams including multiple partners (Analytics, Quality Assurance, Clinical Operations, Medical Devices, Regulatory Affairs, Industrial Affairs). For later stage programs, he/she will lead the transfer to the Industrial Affairs
• Manage technicians, formulation scientists, interns, PhDs, post-docs
• Propose and lead innovation initiatives, internally or in collaboration with external laboratories, participate in due diligences
• Write scientific articles and patents, present his/her work in scientific conferences
• Contribute to several department-related transversal tasks (scientific, organizational, Health and Safety, etc.) and working groups

THE PROFILE OF THE COLLEAGUE WE’D LOVE TO WORK WITH

• A scientific degree with a PhD in Biology/Chemistry/Engineering/Pharmacy
• A first working experience in industry with the development of biological products (antibodies, antibody-drug conjugates, fusion proteins, etc.) in liquid and/or lyophilized forms
• Experience with formulation development and characterization of proteins (UV, HPLC, CGE, cIEF, Karl-Fischer, sub-visible particle analysis, light scattering techniques, etc.)
• Strong scientific background and curiosity
• Excellent communication, technical writing skills (development reports, experimental protocols, technology transfer reports) and oral presentation skills in English
• People management experience
• Project management skills and experience is a plus
• Ability to work effectively in an interdisciplinary team-based environment
• A good English and French level is required

What you may expect in terms of development opportunities

In this position, you will be able to develop your skills in 3 directions: scientific, by addressing and solving unique technical challenges, organizational, by working in the multi-dimensional network of a large and global company, and managerial, by accompanying and supporting the development of your collaborators. Your work at the crossroads of multiple functions and expertise will give you the opportunity to evolve into larger managerial responsibilities, or into cross-functional project leadership roles, or to move to other areas of pharmaceutical and product development.

PURSUE PROGRESS, DISCOVER THE 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!

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.