Associate Director, Process Data Analytics
Core
Lead process data analytics, statistical modeling, and data infrastructure for real-time monitoring of cell and gene therapy manufacturing processes to support late-stage clinical development and regulatory submissions.
Role type
Senior IC data scientist (process analytics & CMC)
Builds
Production ML models | dashboards & analysis | infrastructure
Domain
Biopharma / Cell and Gene Therapy
Deliverable
production ML models
Required skills
Statistical modeling, Python, SQL, SAS, SIMCA, JMP, Minitab, GMP process data analytics, SPC, CMC regulatory documentation, data infrastructure design, cross-functional leadership
Preferred skills
Generative AI tools, pandas, NumPy, scikit-learn, Power BI, XGBoost, experience with CDMOs/CTLs
Technologies
Python, SQL, SAS, SIMCA, JMP, Minitab, Tableau, Power BI, Spotfire, EBR, MES, LIMS, SCADA
Responsibilities
Deliver statistical modeling and process monitoring; synthesize technical data for governance; establish data infrastructure; build interactive dashboards; author CMC regulatory documentation; lead process monitoring program with SPC; support PPQ readiness and tech transfer; manage internal and external resources.
Seniority
Senior, hands-on IC with strategic leadership