Beschreibung

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.
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