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

What You Will Achieve

• 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.

Qualifications: Must Have

• 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.

Qualifications: Nice to Have

• Experience authoring CMC regulatory submissions, specifically stability sections, shelf-life or retest-period justifications, stability commitments, and responses to health authority questions.
• Experience designing and executing clinical and registration stability programs for drug substances and drug products.
• Experience with stability trending, shelf-life assignment, retest-period strategy, comparability assessments, and specification development.
• Experience supporting storage-condition assessments, temperature excursions, and stability-related investigations.
• Experience working with internal and external GMP laboratories, contract research organizations, and manufacturing partners.
• Experience supporting audits, inspections, corrective and preventive actions, and inspection-readiness activities.
• Familiarity with small molecules, peptides, biomolecules, conjugates, or other advanced pharmaceutical modalities.
• Experience applying digital technologies, automation, data visualization, or responsible AI solutions to support scientific decision making.
• Demonstrated scientific leadership through cross-functional influence, publications, presentations, or industry engagement.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

Work Requirements

• Ability to operate effectively in a highly collaborative, multidisciplinary environment.
• Commitment to quality, compliance, and continuous improvement.
• Limited domestic and/or international travel may be required.
• Work Location Assignment: On Premise, Groton, Connecticut.