Principal Scientist, PSSM ARD, GMP Analytics, Stability Strategy & Operations
About The Position
At Pfizer, our purpose is to deliver breakthroughs that change patients’ lives. In this role, you will help convert analytical science, product knowledge, and regulatory expectations into robust stability strategies that support the development of new medicines. Your scientific judgment and focus on quality will help teams make well-supported decisions and deliver reliable stability information for patients and health authorities. As a Principal Scientist in Analytical Research & Development, GMP Analytics, you will be recognized as a technical expert and significant scientific contributor in pharmaceutical stability. You will lead through influence across multidisciplinary teams and support stability programs from clinical development through registration. You will connect strategy with execution by helping teams design meaningful studies, interpret trends, resolve technical issues, and communicate stability conclusions in regulatory and quality documents. This is an individual contributor role for a scientist who can operate with independence, collaborate effectively, and provide clear technical direction across internal and external interfaces. The position does not require formal people-management responsibility.
Requirements
- 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.
Nice To Haves
- 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. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, includingrisk management and ethical use
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.
Benefits
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
- Relocation support available
- Relocation assistance may be available based on business needs and/or eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
