Director, CMC Quantitative Sciences
Core
Lead a team of statisticians and data scientists to deliver advanced quantitative solutions for Chemistry, Manufacturing, and Controls (CMC) across the product lifecycle, including regulatory filings, lifecycle management, and automated monitoring of manufacturing and stability data.
Role type
Director, CMC Quantitative Sciences
Builds
Regulatory submissions, lifecycle management strategies, automated monitoring tools, stability data dashboards, and analytics platforms.
Domain
Biopharmaceuticals / CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Statistical methods for CMC (stability, DOE, regression, multivariate analysis, control charts), R, Python, JMP, SAS, Spotfire, Power BI, Tableau, GMP quality concepts, regulatory expectations (ICH, WHO, USP), team leadership, mentorship, technical storytelling.
Preferred skills
Manufacturing and analytical systems (LIMS, MES, OSI PI, SAP), eCTD submissions, risk-based decision making.
Responsibilities
Define and execute statistical strategies for CMC objectives; provide expert statistical consultation to senior leaders; lead design of complex experimental and statistical models; oversee portfolio of high-impact projects; manage a team of 5-6 CMC statisticians and data scientists; partner with cross-functional teams to embed statistical thinking; guide regulatory strategy and agency interactions.
Seniority
Director, strategic leadership with hands-on technical expertise
