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

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

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Job summary

Pfizer is seeking a Principal Scientist in Analytical Research & Development, GMP Analytics, to lead stability strategies for drug programs and provide technical direction across interfaces. Based in Groton, CT, the role emphasizes independence, collaboration, and regulatory-compliant science.

You will design protocols, oversee data analyses, and contribute to regulatory submissions while promoting data integrity and continuous improvement.

Qualifications

• PhD with 4–8 years of relevant experience in analytical development or stability.
• MBA/MS with at least 9 years of relevant experience in pharmaceutical development.
• BA/BS with 12+ years of relevant experience in GMP environments or related fields.

Responsibilities

• Lead stability strategies for assigned drug programs and communicate across teams.
• Design stability protocols, test plans, and regulatory documentation.
• Evaluate stability results, identify risks, and partner with cross-functional experts.

Skills

Analytical development

Cross-functional collaboration

Technical writing

Regulatory documentation

Data interpretation

GMP knowledge

Quality systems

Education

PhD with 4–8 years

MBA/MS with 9+ years

BA/BS with 12+ years

Tools

Analytical software

Job description

Use Your Power for Purpose

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.

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.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, includingrisk management and ethical use.

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.
• Relocation support available.
• Relocation assistance may be available based on business needs and/or eligibility.

Salary and Compensation

The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program.

Benefits

We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

• 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

Salary Disclaimer

Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Sunshine Act

Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.

Accessibility

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Research and Development

Research and Development Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.