Scientific Technical Lead, Early Stage PDST CMC
Core
Senior individual contributor role embedding AI and advanced analytics into early-stage biologics pipelines to accelerate process development, robustness, and control strategy.
Role type
Senior IC scientific data scientist (biologics CMC)
Builds
Predictive models, analytical frameworks, and intelligent workflows for upstream/downstream bioprocess optimization and digital twin concepts.
Domain
Biopharma / Biologics Process Development / CMC
Deliverable
production ML models
Required skills
Python (expert), statistical modeling, hybrid modeling (first-principles + data-driven), experimental design (DoE, Bayesian optimization), GxP compliance, MLOps, data architecture
Preferred skills
Advanced degree in Data Science/Biostats/Chemical Engineering, experience with LIMS/MES/DeltaV data, knowledge graph/LLM systems
Technologies
PyTorch, TensorFlow, R, Dataiku, AWS SageMaker, Spark, Tableau
Responsibilities
Develop and deploy predictive models for upstream/downstream performance and CQA outcomes; design experiments using DoE and active learning; architect data strategies and ensure GxP compliance; translate complex analyses into actionable insights for cross-functional teams.
Seniority
Senior, hands-on IC
