Senior Principal Scientist

Use Your Power for Purpose

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. At the core of this mission is Research and Development, where we strive to transform advanced science and cutting-edge technologies into the most impactful therapies and vaccines. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your role is crucial. You will leverage innovative design and process development capabilities to accelerate the delivery of best-in-class medicines to patients globally.

What You Will Achieve

• The selected candidate will serve as a Manager within the Quality Control, Stability and Validation group, which is part of the Analytical R&D organization. This role involves supervising a team of 3-6 scientists and contributing to both late-stage analytical regulatory submissions for vaccines, monoclonal antibodies (mAb), mAb conjugates, and early-stage strategies that may affect commercial filings.

• Responsibilities include engaging with external stakeholders, health authorities, and industry peers to support analytical submission strategy and regulatory approval processes.

• The candidate should possess comprehensive knowledge and experience in analytical procedures and requirements from development through registration and be able to work effectively in a matrix-based environment supporting biotherapeutics registration.

• This role will oversee a team that develops strategic submission approaches aligning with regulatory standards and prepares analytical sections for dossiers. Collaboration with various analytical, regulatory, and project groups will be necessary to ensure consistent commercial submission content across different modalities.

Role Responsibilities:

• Oversee 3–6 analytical regulatory authoring staff responsible for preparing and reviewing CMC sections for IND/IMPDs and license applications, while managing project team support with additional contract personnel.

• Coordinate with cross-functional project teams to plan, budget, and allocate resources for late-stage analytical CMC regulatory authoring activities.

• Act as the primary sponsor and main point of contact for partner contract organizations on analytical regulatory and technical authoring matters.

• Utilize comprehensive knowledge of regulatory submission requirements through collaboration with stakeholders throughout the submission development process.

• Serve as a key strategist for ARD by partnering with various lines and cross-functional project teams, proactively communicating updates on current regulatory trends, scientific innovation, global harmonization, and external factors influencing CMC strategies.

• Collaborate across the Pfizer network to author and review analytical regulatory documentation, proactively addressing emerging submission opportunities and regulatory challenges.

• Design and assign training materials related to business processes for direct reports.

• Representing ARD on internal and external teams interfacing with GCMC, Quality, PGS, and Portfolio Management, contributing to cross-organizational initiatives and processes that impact submission quality and regulatory approvals

Qualifications

Must Have

• PhD with 8 years of experience OR BS with 15+ years of experience working in interdisciplinary drug development teams, with professional background in a cGMP environment OR MS with 11+ years of experience working in interdisciplinary drug development teams, with professional background in a cGMP environment

• A degree in biology, biochemistry, immunology, molecular biology, analytical chemistry, or a closely related discipline is required.

• Experience in biological drug development and familiarity with analytical strategies to support product development and evaluate the quality and characteristics of biotherapeutics.

• Working knowledge of technologies for biomolecule and conjugate analysis, including ELISA, separations, qPCR, and compendial assays, is expected.

• Direct experience with clinical and commercial biologics submissions, as well as understanding of regulatory submission requirements, is required.

• Strong written and verbal communication skills, proficient time management, innovation, and adaptability to both independent and team environments within multidisciplinary and fast-paced settings are required.

• Demonstrated ability to deliver results under pressure and communicate effectively with project teams and regulatory authorities is needed.

• Experience managing personnel either throug