Stability Scientist
Core
Design, manage, and evaluate stability studies to determine shelf life, storage conditions, and transport requirements for injectable dermatology products.
Role type
Stability Scientist (Pharmaceutical Quality)
Builds
Injectable aesthetics and therapeutic dermatology products
Domain
Dermatology / Pharmaceutical Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
stability study design and execution, GxP compliance, regulatory submission support, data analysis and interpretation, deviation investigation, CAPA management, technical documentation, cross-functional collaboration
Preferred skills
lifecycle management, temperature excursion assessment, continuous process improvement
Technologies
LIMS
Responsibilities
Design, plan, execute, and document stability studies for development and commercial products; Author study protocols, stability reports, scientific assessments, and stability statements; Analyse and interpret stability and analytical data to support shelf-life assignment and product lifecycle decisions; Manage stability studies in LIMS and ensure documentation is accurate, complete, and compliant; Support regulatory submissions and responses to health authority questions related to stability; Contribute to deviation investigations, root cause analyses, and CAPA activities; Assess temperature excursions, transport deviations, and their potential impact on product quality
Seniority
Mid-Senior, hands-on IC
