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/validationImplement/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 formulationsReview SOPs, validation protocols (propose a validation design), validation reportsEvaluate, recommend, and implement new analytical technologies and instrumentation Provide project oversight and ensure adherence to project timelinesPresent experimental approaches, and results of analytical method development at internal/External meetingsSupport mRNA and LNP process development through development of analytical methods and performing testing in close coordination with the mRNA process development teamSupervise 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

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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 validationAbility to propose appropriate method improvementExcellent verbal and written communication skillsAble to work independently and collaborate in team, enthusiastic and self-motivatedGood sense for initiative and quality, accuracy and detail, team playerDemonstrate 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

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

#LI-FRA

#LI-Onsite

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, ability or gender identity.

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