Biologics Process Expert
Core
Lead shipping validation strategies for biologics drug substance and drug product from development to commercial supply, applying AI and advanced analytics to ensure product quality and patient availability.
Role type
Senior IC Biologics Process Expert (Shipping Validation & Digital Innovation)
Builds
Robust shipping validation strategies, predictive models, and digital tools for biologics transport.
Domain
Biopharmaceuticals / Biologics Manufacturing & Logistics
Deliverable
production ML models
Required skills
Biologics process development, protein stability under stress, shipping validation study design, AI-enabled tools, advanced analytics, ISTA standards, technical writing, cross-functional collaboration
Preferred skills
Cold chain logistics, container closure systems, computational modeling, regulatory inspections, GxP quality risk management
Technologies
AI tools, advanced analytics platforms, digital twins, DOE, multivariate analysis
Responsibilities
Lead DS and DP shipping validation strategies; design and interpret shipping studies (temperature, vibration, shear); apply mechanistic and digital models to assess transport risk; automate data analysis and reporting; collaborate with formulation, manufacturing, and supply chain teams; author regulatory documentation; mentor colleagues on standards and frameworks.
Seniority
Senior, hands-on IC with mentorship responsibilities