Sanofi
biopharma
AnalyticalLeadandExpertPreclincalBioassays
Neural analysis suggests this role is
optimal for Senior candidates.
“Analytical Lead and Expert Preclincal Bioassays at Sanofi. Skills: Analytical Lead, Expert Preclincal Bioassays, Analytical Life Cycle Management, Method Transfer/Validation, bioassays, automation. Serve as the primary contact for assigned product / product family for the MSAT Global Analytical function. Represent Global MSAT Analytical in CMC/technical product teams”
What You'll Achieve.
overseeing, leading and coordinating execution of analytical activities for late stage and commercial biologics; support the launch of new products; ensure execution of analytical work within MSAT and externally to support characterization, comparability, investigations, and process development; development of analytical control strategy specification setting, risk assessment and comparability activities related to new product introduction, process changes, tech transfer, etc. as appropriate; Lead / oversee ALCM activities including automation, internally and externally/outsourced as applicable, including assay development, transfer, SME support for assigned product(s)
Industry & Context.
Anticipate risk; bring about proactive, effective and innovative solutions
What They're Looking For.
Must Have
5+ years’ experience in development and manufacturing of biopharmaceutical products, preferably in analytical sciences, Experience with analytical transfers, bioassays, automation, development, regulatory requirements, dossier writing, cGMP knowledge, HA regulations and interactions, Fluency in English and German, verbally as well as in writing
What You'll Do.
Serve as the primary contact for assigned product / product family for the MSAT Global Analytical function
Represent Global MSAT Analytical in CMC/technical product teams
maintain thorough knowledge of assigned product(s)
ensures execution of analytical work within MSAT and externally to support characterization
and process development
Coordinate and follow-up on experiments at external suppliers for bioassays
Responsible for development of analytical control strategy specification setting
risk assessment and comparability activities related to new product introduction
Lead / oversee ALCM activities including automation
internally and externally/outsourced as applicable
including assay development
SME support for assigned product(s)
Provide input to regulatory dossiers
provide responses to questions from authorities
How You'll Work.
Team & Collaboration
Serve as a member of Technical Product Team(s); Represent Global MSAT Analytical in CMC/technical product teams; Enjoying collaboration in interdisciplinary teams
Communication Scope
Ability to present even complex contexts accurately and comprehensibly
Process & Methodology
coordinating execution of analytical activities, coordinate and follow-up on Insulin-bioassays running at external suppliers, Lead / oversee ALCM activities
Full Job Description
**_About the job_** As Analytical Lead, you will serve as a member of Technical Product Team(s) for a product or a portfolio of products and will be responsible for overseeing, leading and coordinating execution of analytical activities for late stage and commercial biologics. Additionally, you will coordinate and follow-up on Insulin-bioassays running at external suppliers. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Expert for Analytical Life Cycle Management and Method Transfer/Validation within our MSAT, will be to support the launch of new products. **About Sanofi:** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main responsibilities:** * Serve as the primary contact for assigned product / product family for the MSAT Global Analytical function. Represent Global MSAT Analytical in CMC/technical product teams, maintain thorough knowledge of assigned product(s), ensures execution of analytical work within MSAT and externally to support characterization, comparability, investigations, and process development. * Coordinate and follow-up on experiments at external suppliers for bioassays * Responsible for development of analytical control strategy specification setting, risk assessment and comparability activities related to new product introduction, process changes, tech transfer, etc. as appropriate. * Lead / oversee ALCM activities including automation, internally and external
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