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mRNA Analytical Development QC – mRNA Quality Control Scientist
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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.
This job offer is accessible to all, regardless of gender.
Job title: mRNA Analytical Development - Quality Control Scientist
- Location: Marcy-l'Etoile
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
Education:
- Engineer/MSc or PhD in Biochemistry & Biophysics with a min of 5 years of experience in in a pharma / biotech company
#mRNA
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