Director, CMC Quantitative Sciences
Moderna
Summary
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.
Job description
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.
Requirements
- 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
- 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
Benefits
- Competitive healthcare
- Voluntary benefit programs
- Fitness support
- Mindfulness support
- Mental health support
- Family planning benefits
- Fertility support
- Adoption support
- Surrogacy support
- Paid time off
- Vacation
- Volunteer days
- Sabbatical
- Global recharge days
- Discretionary year-end shutdown
- Savings and investments
Company overview
Moderna, Inc. is a pioneering American biotechnology and pharmaceutical company headquartered in Cambridge, Massachusetts, that has revolutionized the field of medicine through its groundbreaking messenger RNA (mRNA) technology. Founded in 2010, the company has established itself as a global leader in RNA therapeutics, primarily focusing on mRNA vaccines and treatments. Moderna's innovative platform uses mRNA to provide cellular instructions for producing proteins that trigger immune responses, creating a new category of medicines with significant potential to improve patient outcomes across various therapeutic areas. The company gained worldwide recognition during the COVID-19 pandemic for developing one of the earliest and most effective mRNA vaccines, which demonstrated the transformative potential of its technology platform. Beyond infectious diseases, Moderna is advancing a diverse pipeline of 44 treatment and vaccine candidates across infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune conditions. With approximately 5,800 employees and a strong commitment to scientific innovation, Moderna continues to expand its manufacturing capabilities and research initiatives to deliver the greatest possible impact through mRNA medicines.