- Hiring Manager: Ewoud van Tricht
- Location: Amsterdam
About the job
This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Bioprocess analytics (BPA) and characterization (CHAR) group has the overall responsibility to develop robust analytical methods to support the Process Development team on PM21 and cell therapy manufacturing development processes. The group oversees and is responsible for in-depth product characterization by establishing new state-of-the-art technologies, executing and collaborating with experts on structure/function studies. In addition, the group develops platform assays and transition these to a high throughput, automated structure.
The primary accountability of the BPA/CHAR Scientist is to develop analytical, immunological, and cell-based methods, to support the PM21 and Cell Therapy Process Development teams. In addition, perform and collaborate on PM21/NK product characterization and establish HTP and automation method development.
- Develop methods to support Process Development and Characterization on PM21 and cell therapies
- Evaluate and implement new technologies, with an emphasis on state-of-the-art technologies analytical assays
- Perform and collaborate with internal and external experts on product characterization and structure/function studie
- Act as a Subject Matter Expert with respect to analytical analyses within the department as well as cross-functionally
- Design and execute advanced experimental plans and data analysis methods, write and review high quality reports
- Represents the department and actively participates in scientific discussions with other R&D scientists
- May provide technical oversight and manage the workload for a few associate scientists
- Support cross functional investigations, continuous improvements, and risk assessments
- Leads internal and external assay transfers consistent with established Sanofi procedures
- Due to nature of activities, there may be occasionally work outside daily office hours or in the weekends
- This role will require hands on experimental work in the lab
- Occasionally contributing to BPA testing to support Process Development on PM21 and cell therapies
- Ph.D. or Master’s in bio-pharmaceutical sciences, biomedical sciences, analytical sciences or related discipline
- 2+ years (Ph.D.) or 4+ years (Master’s) of experience in a related field, preferably in industrial biopharmaceutical analytical development
- Excellent knowledge and hands-on experience with bioanalytical and biophysical assays like capillary electrophoresis, field flow fractionation, liquid chromatography, dynamic light scattering, or particle (size)
- Experience with the analysis and characterization of biological products like cells, proteins, viruses, bacteria, or extracellular vesicles
- Outstanding interpersonal and communication skills
- Problem solving, technical writing and verbal communication skills
- Clearly conveys information and concepts/principles
- Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
- Demonstrated team player with experience contributing to multi-disciplinary project teams
- Strong sense of quality and ownership
- Self-motivated with excellent organization and time-management skills
- Innovative, critical, and creative thinker
- Theoretical understanding of primary cell culture, flow cytometry, cell-based assays and ELISA, Next generation sequencing (NGS), Analytical Ultra Centrifuge, and mass spectrometry
- Advanced skills in statistical data analysis and design of experiments (DOE)
- Experience with the development of bioanalytical methods according to Analytical Quality by Design (AQbD) and related guidelines ICH Q14 and USP <1220> is of advantage
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