Principal Scientist – GMP Analytics & Stability

RiseMe; Groton (CT); On-site; USD 106,000 - 177,000; Full time

Job summary

Pfizer is seeking a Principal Scientist in Analytical Research & Development, GMP Analytics, to lead stability programs from clinical development through registration. You will design stability studies, interpret trends, and communicate conclusions for regulatory and quality documents.

This role emphasizes independence, collaboration, and data integrity, with opportunities to mentor colleagues and apply AI-enabled tools to improve oversight and decision making across stability processes.

Qualifications

• BA/BS with at least 12 years of relevant experience; or MBA/MS with at least 9 years of relevant experience; or PhD with 4 to 8 years of relevant experience.
• Experience in pharmaceutical analytical development, stability sciences, product quality, or a related technical discipline within a regulated GMP environment.
• Demonstrated understanding of pharmaceutical stability principles, ICH stability guidance, and quality-system expectations.
• Proven ability to interpret complex analytical and stability data and communicate clear scientific conclusions.
• Experience working effectively in cross-functional, matrixed environments.
• Strong technical writing and presentation skills.
• Demonstrated ability to deliver results while balancing scientific rigor, compliance, and project timelines.
• Ability to influence and collaborate with peers and stakeholders across disciplines.
• Experience with a broad range of software and information systems and the ability to learn new technologies and tools.

Responsibilities

• Lead the development and communication of scientifically sound, phase-appropriate stability strategies for assigned drug substance and drug product programs.
• Design and oversee stability protocols, storage conditions, pull schedules, test plans, data assessments, technical reports, and regulatory support documentation.
• Evaluate stability results and trends, identify technical and compliance risks, and partner with cross-functional experts to develop appropriate actions and recommendations.
• Author and critically review stability protocols, reports, scientific assessments, investigations, specifications, and responses to technical questions.
• Contribute to global regulatory submissions and partner with Regulatory Affairs colleagues to communicate stability data, conclusions, shelf-life assessments, and commitments clearly.
• Support the preparation, authoring, and review of Chemistry, Manufacturing and Controls (CMC) regulatory content.
• Coordinate stability activities across Pfizer laboratories and external testing partners, ensuring data quality, compliance, and timely execution.
• Support GMP investigations, deviations, corrective and preventive actions, audits, inspections, and health authority responses that involve stability-related topics.
• Promote data integrity, inspection readiness, and continuous improvement across stability processes and interfaces.
• Apply digital technologies, data analytics, visualization tools, and AI-enabled solutions to improve stability oversight and decision making.
• Mentor colleagues and provide technical guidance within multidisciplinary project teams.
• Ensure data are appropriately reviewed, archived, and reported in accordance with Pfizer procedures and regulatory expectations.

Job description

Pfizer is seeking a Principal Scientist in Analytical Research & Development, GMP Analytics, to lead stability programs from clinical development through registration. You will design stability studies, interpret trends, and communicate conclusions for regulatory and quality documents.

This role emphasizes independence, collaboration, and data integrity, with opportunities to mentor colleagues and apply AI-enabled tools to improve oversight and decision making across stability processes.