mRNA GMP Scientist

Sanofi

Marcy-l'Etoile, France

About the job

As a mRNA scientist in the QC lab, you will be in charge to support analytical activities for optimization, and qualification/validation of analytical methods essential for the release of mRNA vaccines and raw materials. you will contribute in the clinical batch release and method transfers to M&S.

Main responsibilities:

Oversee all analytical aspects to support mRNA/LNPs production (raw materials, drug substance, drug product), including routine sample analysis, release/stability testing, new analytical method development, method qualification/validation
Implement/develop/interpret analytical measurements using chromatographic methods (UV/CaD) or mass spectrometry and perform testing for raw materials, mRNA drug substance and mRNA-LNP drug product. Manage transfer of analytical methods for analysis of raw materials/excipients, drug substance, and drug product formulations
Review SOPs, validation protocols (propose a validation design), validation reports
Evaluate, recommend, and implement new analytical technologies and instrumentation
Provide project oversight and ensure adherence to project timelines
Present experimental approaches, and results of analytical method development at internal/External meetings
Support mRNA and LNP process development through development of analytical methods and performing testing in close coordination with the mRNA process development team
Supervise and manage work of technician(s)
Stay informed on current regulatory guidance for mRNA drug development and serve as the subject matter expert in mRNA regulatory strategy

About you

Experience and Skills:

Strong experience in various chromatographic, spectroscopic techniques such as mass spectrometry, HPLC UV-Vis/Cad, as well as other specialty instrumentation including but not limited, SoloVPE, Karl Fisher, particle sizers, etc.
Strong experience in GMP lab and method validation
Ability to propose appropriate method improvement
Excellent verbal and written communication skills
Able to work independently and collaborate in team, enthusiastic and self-motivated
Good sense for initiative and quality, accuracy and detail, team player
Demonstrate Play to Win Culture Behaviours