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 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 collaborative, detail-oriented, proactive, and comfortable working in a fast-paced environment where filing quality, compliance, and timeline discipline are all critical, with a desire to make an impact as part of a company that is Bold, Relentless, Curious, and Collaborative.

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. 

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

-