Scientific Director, Pharmaceutical Development Analytics
Core
Portfolio-level statistical authority for drug product development and lifecycle management, applying advanced statistical analysis and modeling to optimize formulations and processes.
Role type
Senior IC quantitative scientist (pharmaceutical development)
Builds
Drug product development programs from post-Proof of Concept through regulatory submission and commercial lifecycle
Domain
Biopharmaceuticals / Pharmaceutical Development (CMC)
Deliverable
production ML models | product features
Required skills
Design of Experiments (DoE), multivariate analysis, statistical modeling of manufacturing processes, formulation principles, solid oral dosage formulation, regulatory submission support (NDA/BLA/MAA), JMP, R, Python
Preferred skills
Hands-on experience with unit operations (granulation, blending, compression, coating), process capability and variability analysis, data science approaches
Technologies
JMP, R, Python
Responsibilities
Own drug product design and development strategy, provide advanced statistical analysis and modeling expertise across CMC programs, serve as technical authority for statistical interpretation, support formulation and process development strategies, ensure statistical rigor and regulatory defensibility of CMC data packages, mentor scientists on quantitative approaches
Seniority
Senior, hands-on IC
