Senior Data Scientist, CMC
Core
Build and deploy mechanistic, hybrid, and data-driven models to optimize drug substance, drug product, packaging, and labeling processes for small molecule and oligonucleotide programs.
Role type
Senior IC data scientist (pharma process development)
Builds
Production ML models, FAIR data products, and dashboards for CMC processes and technology transfer
Domain
Biopharmaceuticals / Chemical Engineering / Process Development
Deliverable
production ML models
Required skills
Python, SQL, Databricks, statistical analysis, DoE, process modeling, AI/ML application, regulatory data integrity (cGMP/ALCOA+)
Preferred skills
Experience with CDMOs/CROs, digital product ownership, LLM-based tools, packaging/labeling operations
Technologies
Databricks, Power BI, Tableau, Spotfire
Responsibilities
Develop predictive models for unit operations (blending, granulation, compression, coating, fill/finish); build reusable data pipelines integrating internal and external data; apply AI/ML to accelerate data review and knowledge capture; present recommendations to stakeholders and contribute to regulatory filings; mentor colleagues in data science practices.
Seniority
Senior, hands-on IC