Director, CMC Quantitative Sciences
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Benefits offered by this job
Job summary
Moderna is hiring a Director of Quantitative Science in Norwood, MA. You will lead a small team of statisticians and data scientists delivering advanced quantitative solutions across the product lifecycle, from regulatory filings to automated monitoring of manufacturing data.
You will shape scientific strategy, guide regulatory submissions, and deploy scalable data-driven tools across GMP and non-GMP environments, collaborating with Process Development, Analytical Development, Quality,
Qualifications
- PhD/MS/BS with long relevant experience in statistics for CMC applications.
- Proven leadership of complex statistical projects in fast-paced environments.
- Ability to mentor and develop a high-performing team.
- Deep expertise in CMC statistical methods: stability, DOE, regression.
- Strong storytelling and communication for non-technical stakeholders.
- Experience with automated process monitoring and data pipelines.
- Familiarity with regulatory expectations (ICH, WHO, USP).
Responsibilities
- Define and execute statistical strategies supporting CMC and business goals.
- Provide expert statistical guidance to senior leaders across cross-functional teams.
- Lead design and application of complex experimental models for stability and lifecycle management.
- Translate business needs into scalable data science tools for real-time trending and analysis.
- Oversee projects from regulatory filings to digital tools ensuring quality and timelines.
- Govern analytics platforms and governance for data in GMP and non-GMP environments.
- Mentor and develop team members; drive internal upskilling and excellence.
Skills
Education
Tools
Job description
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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.
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.
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.
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.
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.
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.
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