Principal Research Associate, Analytical Development

Job description

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 workstreams with rigor, urgency, and attention to detail. Here’s What You’ll Do 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, coordinating SME assessments, and helping develop clear scientific rationale and documentation for APL and governance review. Partner with Regulatory CMC and Quality to ensure analytical submission content and supporting documentation are developed in accordance with applicable FDA, EMA, ICH, pharmacopeial, GMP, data-integrity, and document-control expectations. Support preparation for regulatory interactions, including briefing materials, technical question-and-answer packages, data summaries, and follow-up actions related to analytical and product-quality topics. Build and maintain durable program knowledge across vaccine products by organizing prior health-authority feedback, filing precedents, analytical decisions, commitments, and lessons learned so that future submissions and ASU cycles can be executed efficiently and consistently. Identify opportunities to standardize templates, trackers, authoring practices, and evidence packages across vaccine programs to reduce rework, improve filing quality, and increase the efficiency and scalability of APL execution. Here’s What You’ll Need (Basic Qualifications) M.S. with 5+ years or B.S./B.A. with 8+ years of relevant biotechnology or pharmaceutical industry experience in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Biology, Chemical Engineering, or a related scientific discipline, with experience in Analytical Development, CMC, Quality, Regulatory support, or a related technical development function. Here’s What You’ll Bring to the Table (Preferred Qualifications) Strong scientific foundation with practical understanding of analytical development for biologics, vaccines, nucleic-acid therapeutics, or other advanced modalities, including analytical methods, specifications, stability, characterization, comparability, and critical quality attributes. Demonstrated experience supporting preparation of CMC regulatory submissions, analytical filing content, health-authority information requests/RtQs, or other regulatory-facing technical documentation. Prior experience supporting an Analytical Program Lead, analytical lead, CMC product lead, Regulatory CMC lead, or similar cross-functional technical leadership role is strongly preferred. Experience with vaccine development and lifecycle activities is highly desirable; experience supporting seasonal vaccines, strain-change/variant updates, accelerated filing cycles, or comparable high-cadence regulatory updates is a significant advantage. Working knowledge of global CMC regulatory expectations and guidance, including FDA, EMA, ICH, and applicable pharmacopeial requirements, with the ability to distinguish scientific requirements from procedural or compliance requirements. Strong understanding of phase-appropriate GMP principles, data integrity, document control, change management, and the importance of traceability between raw data, approved technical reports, regulatory narratives, and commitments. Ability to critically interpret analytical data and technical reports, recognize inconsistencies or missing evidence, ask scientifically meaningful questions, and synthesize complex inputs into concise and defensible conclusions. Excellent technical writing and editing skills, with experience producing clear, accurate, internally consistent, and regulator-ready scientific content under tight timelines. Strong organizational and project-execution skills, including experience managing multiple concurrent deliverables, dependencies, data packages, review cycles, and deadlines without losing scientific detail or quality. Experience working cross-functionally with Analytical Development, QC, AS&T/MS&T, Quality, Process Development, Regulatory CMC, Manufacturing, Statistics/Quantitative Sciences, or external testing organizations. Familiarity with electronic document and quality systems such as Veeva, LIMS, electronic notebooks, or related controlled-document platforms is preferred. Demonstrated ability to operate with appropriate independence: capable of owning defined work packages and driving follow-through while recognizing when scientific or regulatory decisions require escalation to the APL, SME, Quality, or Regulatory CMC. Highly c