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

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

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.

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

Relocation support available

Work Location Assignment:On Premise

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. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). 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.

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

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available at Pfizer Careers.

Research and Development