Stability Scientist
On-site · Oslo, Oslo, Norway
Job Summary
Stability Scientist responsible for designing and documenting stability studies to support product lifecycle management, acting as stability SME within Global Product Management. Collaborates across Analytical, Quality, Regulatory, Manufacturing, R&D, and Supply Chain to execute stability studies through lifecycle phases; develops strategies, writes protocols/reports/SOPs, analyzes data and trends to determine shelf life and storage conditions, and leads investigations including CAPA and risk assessments. Requires PhD (preferred) or MSc in Chemistry or related discipline with GMP stability experience; willingness to travel internationally (10–20%). Based in Oslo with some travel to global manufacturing sites. Emphasizes regulatory compliance (ICH, GMP, FDA/EMA), cross-functional communication, and audit readiness; supports regulatory submissions and continuous improvement; Equal Opportunity Employer.
Required Qualifications
- PhD (preferred) or MSc in Chemistry or related discipline with relevant experience
- Solid professional experience in a GMP pharmaceutical environment with expertise in stability program design, regulatory expectations, and CMC principles
- Experience in a GMP-regulated pharmaceutical environment with focus on stability
- Capability to interpret data and communicate across functions and leadership levels
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