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
Deliverable
production ML models | dashboards & analysis | client delivery
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
