Director, CMC Quantitative Sciences

Role: Director of Quantitative Sciences in Moderna’s CMC team, based in Norwood, MA, leading a small team of statisticians and data scientists to develop advanced quantitative solutions across the product lifecycle, including regulatory filings, lifecycle management, and manufacturing monitoring. Responsibilities: define and execute statistical strategies, provide expert consultation to senior leadership, oversee complex experimental designs, develop scalable data-driven tools, and lead analytics platform development for stability, trending, and root cause analysis. Manage a team of 5-6 professionals, foster innovation, and mentor staff. Collaborate across Process Development, Analytical Development, Quality, Manufacturing, and Digital teams to embed statistical methods in development and regulatory strategies, supporting interactions with regulatory agencies including responses and presentations. Drive continuous improvement by adopting emerging tools and methodologies, ensuring adherence to GMP and regulatory standards. Requirements: PhD in Statistics or related field with 10+ years of relevant experience; proven leadership in biopharma statistical projects; expertise in CMC statistical methods (stability, DOE, regression, multivariate analysis, control charts); strong programming skills (R, Python, SAS, etc.); experience with digital data pipelines and regulatory interactions. Preferred: familiarity with manufacturing systems (LIMS, MES), GMP quality concepts, and regulatory submission experience. Work setup: 100% onsite in Norwood, MA, with no travel specified, emphasizing real-time collaboration and hands-on leadership in a high-impact environment.