Scientist Stability
Jobup
- Employment type
- Contract
- Location
- Neuchâtel
- First posted
• 29 June 2026
• 100%
• Temporary
• Neuchâtel
For our partner located in the canton of Neuchâtel, GI Life Sciences is looking for a:
Scientist Stability
Temporary contract
Start date: 01.08.2026
End of mission: 31.07.2027
Your mission:
You are responsible for defining and driving the stability strategy of products.
You ensure regulatory compliance, scientific reliability of data and actively contribute to product life cycle management.
Your responsibilities:
• Define and drive product stability programs as a reference.
• Participate in product transfers to internal or external sites.
• Develop and maintain expertise on product stability profiles within the global supply chain.
• Design, write, validate and supervise stability protocols and associated plans.
• Manage commercial stability annual programs, in coordination with operational teams.
• Write and approve stability reports, regulatory sections (CTD) and responses to health authorities.
• Contribute to change projects by defining and executing necessary stability studies.
• Perform quality impact analyses in the context of change controls and CAPA management.
• Intervene in investigations (OOS/OOT) and related quality analyses.
• Ensure consistency of stability procedures with internal and regulatory standards.
• Participate in continuous improvement initiatives.
• Represent the stability function during health authority audits and inspections.
• Collaborate transversally with R&D, Quality, Production and Supply Chain teams.
Your profile:
• Higher scientific education (chemistry, biology, microbiology or equivalent field).
• Minimum 5 years of experience in a pharmaceutical environment, ideally in stability.
• Very good knowledge of ICH guidelines (Q1A, Q5C) and cGMP regulations (21 CFR).
• Mastery of international regulatory requirements (US, Europe, other regions).
• Good understanding of active substance and finished product manufacturing processes.
• Experience in technical and documentary writing (reports, regulatory files, investigations).
• Mastery of computer tools: MS Office, LIMS, quality systems (TrackWise, Veeva), statistical tools.
• Fluent in French and English.
Automatically translated from the original.
Posted today