Principal Scientist, PSSM ARD, GMP Analytics, Stability Strategy & Operations
Core
Lead the development and communication of scientifically sound stability strategies for drug substance and drug product programs to support new medicine development and registration.
Role type
Principal Scientist, GMP Analytics (Stability Strategy & Operations)
Builds
Robust stability strategies, regulatory submissions (CMC), and quality documentation for pharmaceutical products.
Domain
Pharmaceutical industry, GMP Analytics, Stability Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical stability principles, ICH stability guidance, GMP environment experience, complex analytical data interpretation, technical writing, cross-functional collaboration, regulatory submission support, data integrity, digital technologies/AI application
Preferred skills
CMC regulatory submission authoring, clinical/registration stability program design, stability trending and shelf-life assignment, storage-condition assessment, audit/inspection support, advanced pharmaceutical modalities knowledge, responsible AI practices
Technologies
AI-enabled solutions, data visualization tools, generative AI tools (ChatGPT, Microsoft Copilot), information systems
Responsibilities
Lead development of phase-appropriate stability strategies; Design and oversee stability protocols, test plans, and regulatory documentation; Evaluate stability results and trends to identify risks; Author and review stability reports and CMC content; Coordinate activities across internal labs and external partners; Support GMP investigations and health authority responses; Mentor colleagues and provide technical guidance.
Seniority
Principal, hands-on IC with strategic influence
