Description
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 assignment: 31.07.2027
Your mission:
You are responsible for defining and managing the product stability strategy.
You ensure regulatory compliance, the scientific reliability of data, and actively contribute to product lifecycle management.
Your responsibilities:
- Define and manage product stability programmes as the point of 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 oversee stability protocols and associated plans.
- Manage annual commercial stability programmes 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.
- Conduct quality impact analyses within change controls and CAPA management.
- Engage in investigations (OOS/OOT) and analyses related to quality issues.
- Ensure consistency of stability procedures with internal and regulatory standards.
- Participate in continuous improvement initiatives.
- Represent the stability function during audits and inspections by health authorities.
- Collaborate cross-functionally 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 manufacturing processes for active substances and finished products.
- Experience in technical and documentary writing (reports, regulatory dossiers, investigations).
- Proficient in IT tools: MS Office, LIMS, quality systems (TrackWise, Veeva), statistical tools.
- Fluent in French and English.
