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