Principal Scientist, PSSM ARD, GMP Analytics, Stability Strategy & Operations

As a Principal Scientist in Analytical R&D, GMP Analytics, you apply analytical science and regulatory insight to build robust stability strategies for drug substances and products. You will influence cross-functional teams, guide stability studies from development to regulatory submission, and translate data into reliable conclusions for patients and health authorities. You'll design protocols, interpret trends, resolve issues, and communicate findings in regulatory documents. This role offers the opportunity to shape stability programs within a global pharma context and drive continuous improvement through data-enabled decision making.

• relocation support
• base salary
• bonus target (15% of base)
• long-term incentive program
• 401(k) with Pfizer matching
• comprehensive health benefits

• Lead development of phase-appropriate stability strategies for drug substances and products
• Design and oversee stability protocols, storage conditions, test plans, data assessments, and regulatory support docs
• Evaluate stability results, identify risks, and partner with cross-functional experts for actions and recommendations
• Author and review stability protocols, reports, investigations, and specifications
• Contribute to global regulatory submissions and communicate stability data and shelf-life decisions
• Prepare and review CMC regulatory content related to stability
• Coordinate stability activities across Pfizer labs and external partners to ensure quality and timely execution
• Support GMP investigations, deviations, CAPAs, audits, and health authority responses involving stability topics
• Promote data integrity, inspection readiness, and continuous improvement in stability processes
• Apply digital technologies, data analytics, visualization, and AI-enabled solutions to stability oversight
• Mentor colleagues and provide technical guidance within cross-functional project teams
• Ensure data are reviewed, archived, and reported per Pfizer procedures and regulatory expectations

• BA/BS with 12 years of relevant experience; or MBA/MS with 9 years; or PhD with 4-8 years
• Experience in pharmaceutical analytical development, stability sciences, product quality, within GMP
• Solid understanding of pharmaceutical stability principles, ICH guidance, and quality-system expectations
• Ability to interpret complex analytical data and communicate scientific conclusions clearly
• Experience in cross-functional, matrixed environments
• Strong technical writing and presentation skills
• Ability to deliver results balancing scientific rigor, compliance, and timelines
• Ability to influence and collaborate across disciplines
• Experience with a broad range of software and information systems and capacity to learn new tools

• collaborative
• influencing across disciplines
• clear scientific communication
• pharmaceutical stability principles
• ICH stability guidance
• GMP compliance