Director, 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 Director based in Norwood 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.

Youll 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 Modernas mission helping to expand our pipeline accelerate global impact and uphold our values of being Bold Collaborative Curious and Relentless.

Heres What Youll Do:

Strategic & Technical Leadership

• Define and execute statistical strategies that support Modernas 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 teams effectiveness and agility.

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

Heres What Youll 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. Thats why our benefits and well-being resources are designed to support youat 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 $167000.00 - $300700.00. 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 individuals 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 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 persons 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 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

Were 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 .

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 applicants 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.

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