Principal Scientist, GMP Stability Analytics & Strategy

Pfizer Inc; Connecticut; On-site; USD 106,000 - 177,000; Full time

Benefits offered by this job

Relocation assistance

Comprehensive benefits

Job summary

Pfizer Inc. is seeking a Principal Scientist in Analytical Research & Development, GMP Analytics, to lead stability strategy development and oversight across drug substance and product programs. You will influence across disciplines, design meaningful studies, and ensure data quality and regulatory readiness.

The role emphasizes independence, collaboration, and technical direction with no required people management, supporting global regulatory submissions and stability-related investigations.

Qualifications

• BA/BS with 12+ years in pharma analytical development or stability.
• MBA/MS with 9+ years in relevant field.
• PhD with 4–8 years in GMP stability or related area.

Responsibilities

• Lead development and communication of phase-appropriate stability strategies for drug substances and products.
• Design and oversee stability protocols, storage conditions, test plans and regulatory documentation.
• Evaluate stability results, identify risks, and partner with cross-functional experts for actions and recommendations.
• Author and review stability protocols, reports, and technical assessments.
• Support regulatory submissions and communicate stability data with Regulatory Affairs.

Skills

Stability principles

ICH guidance

Data interpretation

Cross-functional collaboration

Technical writing

Regulatory communication

Education

Bachelor's degree

MBA / MS

PhD

Tools

AI tools (ChatGPT/Copilot)

Job description

Pfizer Inc. is seeking a Principal Scientist in Analytical Research & Development, GMP Analytics, to lead stability strategy development and oversight across drug substance and product programs. You will influence across disciplines, design meaningful studies, and ensure data quality and regulatory readiness.

The role emphasizes independence, collaboration, and technical direction with no required people management, supporting global regulatory submissions and stability-related investigations.