CMC Statistics Director
Core
Strategic and technical leadership for statistical sciences across the pharmaceutical product lifecycle, including process development, manufacturing, validation, and regulatory submissions.
Role type
Director-level CMC Statistics (Scientific Fellow)
Builds
Data-driven decision-making frameworks, statistical governance, and advanced analytics capabilities for CMC functions
Domain
Pharmaceutical manufacturing and biotechnology
Required skills
DOE, multivariate analysis, regression modeling, statistical process control, process validation, stability analysis, regulatory submission support, advanced statistical software proficiency, data integrity principles
Preferred skills
biologics/cell and gene therapy experience, machine learning/AI-enabled solutions, global regulatory inspection support
Technologies
JMP, Minitab, SAS, R, Python
Responsibilities
Establish CMC Statistics Center of Excellence, lead process characterization and optimization, support PPQ/CPV/SPC, develop statistical approaches for method validation, provide stability and comparability support, author regulatory content, deliver statistical training
Seniority
Director, strategic leadership with hands-on technical expertise
