Principal Research Associate, Analytical Development

The Role

In this role, you will join the Analytical Program Lead (APL) team within Analytical Development and serve as a critical scientific and regulatory execution partner to the lead Vaccine APL. You will support analytical control strategy execution and regulatory readiness for vaccine programs, with particular focus on regulatory filings, responses to health-authority questions (RtQs), and Annual Strain Update (ASU) activities. This role requires a strong scientific foundation, a practical understanding of analytical development and product quality, excellent technical writing and data interpretation skills, and working knowledge of global CMC regulatory and compliance expectations.

You will work across APLs, Analytical Development subject matter experts, Analytical Sciences, Product Characterization, Clinical Stability, Process and Product Development, AS&T, QC, Quality, Quantitative Sciences, and Regulatory CMC to translate complex analytical information into accurate, traceable, decision-ready and filing-ready content. Success in this role means enabling the Vaccine APL to operate at the appropriate strategic level while independently driving defined analytical, documentation, and regulatory-support work streams with rigor, urgency, and attention to detail.

• Partner closely with the lead Vaccine APL to execute analytical control strategy and regulatory deliverables for assigned vaccine programs, providing high-quality scientific, documentation, and cross-functional support across development and lifecycle activities.
• Support preparation, authoring, review, and maintenance of analytical CMC content for regulatory submissions, including method, specification, stability, characterization, comparability, and control-strategy narratives, ensuring consistency with source data and approved technical positions.
• Support RtQ activities by interpreting health-authority questions with the APL and Regulatory CMC, coordinating input from appropriate analytical SMEs, assembling supporting evidence, drafting scientifically sound responses, reconciling comments, and tracking commitments through finalization.
• Serve as a key execution partner for vaccine Annual Strain Update activities, helping coordinate analytical readiness for new strains or variants, including method suitability, reference-standard and material strategy, release and stability data, extended characterization, comparability, and associated filing-support packages.
• Maintain integrated trackers for analytical deliverables, submission content, source documents, data availability, decisions, risks, dependencies, and regulatory commitments; proactively identify gaps that could affect filing or ASU timelines and escalate them with proposed paths forward.
• Collect, critically review, and synthesize data and conclusions from Analytical Development, Analytical Sciences, Product Characterization, Clinical Stability, AS&T, QC, Process Development, Quantitative Sciences, and other partners into coherent program-level analytical narratives.
• Perform rigorous scientific and compliance-focused quality checks of filing content, ensuring numerical accuracy, traceability to approved reports and source data, consistency across sections and submissions, alignment of terminology, and appropriate representation of method and product knowledge.
• Support analytical subteam and filing-readiness forums by preparing technical content, documenting decisions and actions, following up on cross-functional commitments, and ensuring that key analytical risks and open questions are resolved on schedule.
• Support specification, method, stability, comparability, and analytical control-strategy updates by organizing the underlying data package,…