Moderna, Inc.

Director, CMC Quantitative Sciences

Moderna, Inc.$167K — $300K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • PhD in Statistics or related field with 10+ years of experience, or MS with 10-15 years, or BS with 15+ years.
  • Proven leadership in managing complex statistical projects.
  • Expertise in statistical methods for CMC applications including stability and regression analysis.
  • Strong communication skills to translate statistical concepts for non-technical stakeholders.
  • Proficiency in statistical programming languages such as R, Python, and experience with tools like Power BI or Tableau.
  • Experience with digital data pipelines and automated process monitoring.
  • Familiar with biopharma regulatory expectations and agency interactions.

Responsibilities

  • Define and implement statistical strategies to meet CMC objectives.
  • Provide statistical expertise to influence product and process decisions.
  • Design complex experimental models for stability and lifecycle management issues.
  • Translate business requirements into scalable data science solutions.
  • Oversee high-impact projects ensuring scientific integrity and alignment with business goals.
  • Serve as a senior statistical expert, ensuring consistency in methodology.
  • Lead development of analytics platforms and best practices in data management.

Benefits

  • Comprehensive healthcare and voluntary benefit programs.
  • Holistic well-being resources, including fitness and mental health support.
  • Family planning benefits including fertility and adoption support.
  • Generous paid time off, including sabbaticals and global recharge days.
  • Savings and investment plans for future financial security.
  • Location-specific perks and extras.
Full Job Description

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 Director based in Norwood, MA. In this role, you will lead a small, high-impact team of statisticians and data scientists responsible for delivering advanced quantitative solutions across the product lifecycle, from regulatory filings and lifecycle management to automated monitoring of manufacturing and stability 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. 

Your leadership 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 and process 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.

Team Leadership & Talent Development

  • Manage a team of CMC statisticians and data scientists (5 - 6 direct reports), overseeing both daily execution and long-term development.

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

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

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.

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

Minimum Qualifications

  • PhD in Statistics or related discipline with 10+ years of relevant experience; MS degree in Statistics or related discipline with 10 - 15 years of relevant experience; or BS degree in Statistics or related discipline with 15+ years of relevant experience

  • Proven track record of leading and delivering complex statistical projects in a fast-paced, dynamic environment

  • Demonstrated leadership and mentorship skills, with the ability to inspire and develop a high-performing team

  • 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, 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 the team on high-value work.

  • Collaborative Leadership: Builds alignment and momentum across functions. Influences without authority and empowers others to lead.

  • 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 $167,000.00 - $300,700.00. 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.

Similar Jobs

More Jobs at Moderna, Inc.

More Pharmaceuticals & Biotech Jobs

Find similar Director, CMC Quantitative Sciences jobs: