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Scientist Stability

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Employment type
Contract
Location
Neuchâtel
First posted
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• 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.

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