Specialist External Analytical Sciences
Core
Provide analytical technical oversight for commercial biologics and vaccines within the global external testing network, ensuring compliance and on-time batch release.
Role type
Specialist External Analytical Sciences (Quality)
Builds
Supports product launches, pipeline acceleration, and uninterrupted supply of commercial products.
Domain
Biopharmaceuticals (Biologics, Vaccines, Large Molecules)
Required skills
Analytical method development and validation, GxP compliance, ELISA, cell-based assays, chromatography, analytical investigations and troubleshooting, project management, regulatory documentation (ICH, USP, Ph. Eur.)
Preferred skills
Experience with IPCs, stability testing, method transfer, lifecycle management
Technologies
ELISA, cell-based assays, chromatography
Responsibilities
Provide analytical oversight for commercial large molecule products; Act as primary technical contact for external labs; Lead analytical investigations and deviations; Drive continuous improvement initiatives; Support method lifecycle activities (transfer, validation, monitoring); Manage projects and timelines; Ensure inspection readiness and author technical documentation.
Seniority
Mid-level, hands-on IC
