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Moderna

Develops mRNA-based medicines for health

Director – CMC Quantitative Sciences

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeNorwood, MA, USA

About the Job

Requirements

  • PhD in Statistics or a related discipline with 10+ years of relevant experience; MS degree in Statistics or a related discipline with 10–15 years of relevant experience; or BS degree in Statistics or a 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, including stability, design of experiments, regression, multivariate analysis, and control charts.
  • Skilled in teaching non-statisticians basic and intermediate statistical methods.
  • Strong programming skills in statistical and data science languages such as R, Python, JMP, and SAS, and experience deploying tools or dashboards such as Spotfire, Power BI, and Tableau.
  • Experience with automated process monitoring, digital data pipelines, and model governance.
  • Familiarity with biopharma regulatory expectations, including ICH, WHO, and USP, and participation in agency communications.

Responsibilities

  • Define and execute statistical strategies that support Moderna’s CMC and business objectives.
  • Provide expert statistical consultation to senior leaders and cross-functional teams, shaping product and process decisions through data analysis.
  • Lead the design and application of experimental and statistical models for stability, comparability, and lifecycle management.
  • Translate business needs into scalable data science solutions, including real-time trending, root cause analysis, and shelf-life estimation tools.
  • Oversee projects spanning regulatory filings, lifecycle extensions, and digital tools, ensuring 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, including stability data monitoring, CPV dashboards and architecture, and automated investigation and 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, including 5–6 direct reports, overseeing daily execution and long-term development.
  • Foster a culture of excellence, innovation, and continuous learning.
  • Mentor team members and 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 across the product lifecycle.
  • Guide regulatory strategy for specifications, comparability, expiry, and post-approval changes.
  • Lead or support regulatory agency interactions, including authoring responses and presenting methodologies in formal meetings.
  • Contribute to initiatives such as seasonal variant updates and expansion of commercial manufacturing capabilities.
  • Stay current with statistical science, regulatory expectations, and biopharma technology.
  • Identify and adopt tools, platforms, and methodologies that enhance team effectiveness and agility.
  • Streamline statistical and data science workflows to reduce time to insight, improve decision-making, and scale innovation.

Desired Qualifications

  • Understanding of manufacturing and analytical systems, such as LIMS, MES, OSI PI, and SAP.
  • Understanding of GMP quality concepts used in pharmaceutical production and development.
  • Experience in regulatory interactions and submissions, including eCTD submissions, responses to health authority questions, and agency meetings.
  • Experience with phase-appropriate GMP principles.
  • Understanding of risk analysis and risk-based decision-making.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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