Head of Migration Strategy and Studies Management

VaudFixeChimie, Pharma, Biotechnologie2019-01-30Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Head of Migration Strategy and Studies Management

Responsibilities:

• Ensure the global function of Head of Migration Strategy and Studies Management within the CoE Pharmaceuticals GPSM Department,
• Manage all relevant activities linked to Packaging Systems migration studies including collaboration with Medical Scientific Affairs, Regulatory Affairs, R&D Project Management; internal and external analytical laboratories, etc...,
• Define the migration studies strategy according to GMPs / GLPs including toxicological and biocompatibility studies,
• Implement CoE Pharmaceuticals Global Packaging Systems Migration Strategy and Studies Management in a pragmatic and business-oriented approach,
• Manage a team of analytical scientists and allocate resource according to projects priorities/budgets,
• Act as global expert for the migration studies domain,
• Manage the toxicological database for packaging systems,
• Consolidate or initiate a pro-active networking on migration related topics (including seminars, conferences, authorities discussions, international working groups, ...).

Profile:

• MSc or PhD in Chemistry, Biochemistry or equivalent,
• Experience in team management of highly educated experts,
• Experience in migration studies (extractibles and leachables) in food or pharmaceutical industries,
• Experience in chemical and biological qualification is a strong asset,
• Capacity to manage biocompatibility testing and toxicological assessments,
• Polymer knowledge would clearly be a plus,
• Fluent in English and French, German is an asset.

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La référence de cette offre est JN -092018-293595 - HAID

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