Principal Scientist, CMC Quantitative Sciences

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.

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.