Sanofi
biopharma
AnalyticalLeadandExpertPreclincalBioassays
“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
Industry & Context.
Anticipate risk and 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
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