Director, Analytical Technical Lead, Global Tech Operations (GTO)
Core
Define and maintain end-to-end analytical strategy for biopharmaceutical products, ensuring method robustness, commercial readiness, and regulatory compliance across the product lifecycle.
Role type
Senior IC analytical technical lead (biopharma)
Builds
Analytical strategies, regulatory submission content, and post-approval change plans for commercial biopharmaceutical products
Domain
Biopharmaceutical industry, analytical science, CMC
Required skills
Analytical science, analytical development, QC, CMC, method robustness assessment, lifecycle management, regulatory submissions (BLA), comparability criteria, analytical trending, JMP, statistical analysis, cross-functional partnership
Preferred skills
Biologics experience, inline/at-line/manufacturing floor deployment, commercial control strategy optimization, method simplification, digital analytics, automation, global post-approval changes
Technologies
JMP
Responsibilities
Define and maintain end-to-end analytical strategy for assigned products; Assess robustness and commercial readiness of analytical methods; Right-size analytical approach to eliminate non-value-added testing; Develop testing location and deployment options (QC lab, manufacturing floor, inline, at-line); Apply statistical tools to evaluate method robustness and support data-driven decisions; Author and review BLA and post-approval analytical content; Establish risk-based comparability strategies for post-approval changes; Lead analytical trending and stability-data evaluation for commercial products
Seniority
Senior, hands-on IC