Principal Scientist, CMC Quantitative Sciences

Principal Scientist, CMC Quantitative Sciences

locations

Norwood, Massachusetts

Technical Development

time type

Full time

posted on

Posted Today

job requisition id

R19738

The Role:

Moderna is seeking an accomplished and visionary Quantitative Scientist to join our Chemistry, Manufacturing, and Controls Quantitative Sciences (CMC QS) team as a Principal Scientist based in Norwood, MA. In this role, you will be responsible for delivering advanced quantitative solutions across the product lifecycle, from regulatory filings and lifecycle management to automated monitoring of CMC data.

You’ll partner closely with colleagues across Process Development, Analytical Development, Quality, Manufacturing, and Digital to shape scientific strategy, guide regulatory submissions, and deploy data-driven tools that directly impact decision-making. Your deep understanding of CMC domains will enable you to identify the most effective approaches to complex technical questions and influence key business outcomes.

This position requires someone who thrives at the intersection of science, systems, and strategy. You should be equally comfortable setting technical vision, navigating regulatory interactions, and translating statistical thinking into practical, scalable tools. The ideal candidate is self-motivated, scientifically curious, and an exceptional communicator.

You will be essential in advancing Moderna’s mission, helping to expand our pipeline, accelerate global impact, and uphold our values of being Bold, Collaborative, Curious, and Relentless.

Here’s What You’ll Do:

Strategic & Technical Leadership

• Define and execute statistical strategies that support Moderna’s CMC and business objectives.

• Provide expert statistical consultation to senior leaders and cross-functional teams; shape critical product, process, and analytical method decisions through robust data analysis.

• Lead the design and application of complex experimental and statistical models for challenges such as stability, comparability, and lifecycle management.

• Translate business needs into scalable data science solutions, including tools for real-time trending, root cause analysis, and shelf-life estimation.

Project & Platform Oversight

• Oversee a portfolio of high-impact projects spanning regulatory filings, lifecycle extensions, and digital tools; ensure scientific quality, timelines, and business alignment.

• Serve as the senior statistical expert on critical programs; set standards, ensure consistency, and advise on methodology choices.

• Lead the development and governance of analytics platforms, such as stability data monitoring, CPV dashboards & architecture, automated investigation & trending tools

• Drive best practices in data creation, pipelining, integration, and reproducibility across GMP and non-GMP environments.

Cross-Functional & Regulatory Engagement

• Partner with Analytical Development, Process Development, Quality, Manufacturing, and Digital teams to embed statistical thinking into all phases of the product lifecycle.

• Guide regulatory strategy for specifications, comparability, expiry, and post-approval changes.

• Lead or support interactions with regulatory agencies, including authoring responses and presenting methodologies in formal meetings.

• Contribute to ongoing initiatives such as seasonal variant updates and the expansion of commercial manufacturing capabilities.

Innovation & Continuous Improvement

• Stay at the forefront of statistical science, regulatory expectations, and biopharma technology.

• Identify and adopt emerging tools, platforms, and methodologies that enhance the team’s effectiveness and agility.

• Streamline statistical and data science workflows to reduce time to insight, improve decision-making, and scale innovation.

• Foster a culture of excellence, innovation, and continuous learning.

• Mentor team members; lead internal training and upskilling efforts to strengthen statistical thinking across the organization.

Here’s What You’ll Bring to the Table:

Minimum Qualifications

• PhD in Statistics (5+ yrs), MS (10 - 12 yrs), or BS (12 - 15 yrs) in Statistics, Biostatistics, Data Science, Applied Mathematics, Chemical Engineering, Biochemical Engineering, or a related STEM discipline.
• Proven track record of leading and delivering complex statistical projects in a fast-paced, dynamic environment
• Deep expertise in statistical methods for CMC applications: stability, DOE, regression, multivariate analysis, control charts, etc.
• Skilled in teaching non-statisticians basic & intermediate statistical methods
• Robust storytelling and communication skills; comfortable translating complex concepts for non-technical stakeholders.
• Strong programming skills in statistical and data science languages (e.g., R, Python, JMP, SAS) and experience deploying tools or dashboards (e.g., Spotfire, Power BI, Tableau).
• Experience with automated process monitoring, digital data pipelines, and model governance.
• Familiarity with biopharma regulatory expectations (ICH, FDA, EMA, WHO, USP) and participation in agency communications.

Preferred Qualifications

• Understanding of manufacturing and analytical systems (e.g., LIMS, MES, OSI PI, SAP).
• Understanding of GMP quality concepts used in pharmaceutical production and development
• Experience in regulatory interactions and submissions, including eCTD submissions, response to health authority questions, and agency meetings
• Experience with phase appropriate GMP principles
• Understanding of risk analysis and risk-based decision making

Competencies

• Strategic Decision-Making: Weighs business impact, scientific rigor, and operational feasibility to drive smart, timely decisions.
• Prioritization & Focus: Knows what matters most. Avoids overengineering and focuses on high-value work.
• Scientific Precision: Brings deep technical expertise and attention to detail, grounded in a genuine passion for data and discovery.
• Executive Communication: Translates complexity into clarity. Communicates insights that are actionable, scalable, and aligned to business needs.
• Agility & Growth Mindset: Embraces new information, adapts to change, and continuously evolves approaches to meet emerging challenges.

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 $142,500.00 - $256,500.00. 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 communiti