Specialist, Sample Management
Core
Manage the lifecycle of drug substance and product samples (in-process, stability, retains) in a biologics manufacturing facility, ensuring timely delivery to QC testing and stability studies while maintaining cGMP compliance.
Role type
Specialist, QC Sample Management
Builds
Supports the release testing of biologics drug products and stability studies for the Global Product Development and Supply network.
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Sample handling and logistics, LIMS/CIMS logging, SOP generation, GMP compliance, deviation reporting, buffer preparation, aseptic manufacturing knowledge, data reconciliation
Preferred skills
Chemistry/Biology degree, pharmaceutical laboratory experience, team collaboration
Technologies
LIMS, CIMS, TempTales, cryogenics logistics systems
Responsibilities
Liaise with manufacturing and warehouse logistics to process and deliver samples; Manage shipping documents and receive samples from external sites; Log samples to LIMS/CIMS and label accordingly; Release samples for QC testing; Store backup and reserve samples; Perform monthly reconciliation and report deviations; Reconstitute and aliquot samples for QC activities; Support buffer preparation for QC Separations lab; Support enrolment and timepoint pulls for stability study samples; Generate and update SOPs; Maintain GMP compliance and complete required training.
Seniority
Specialist, hands-on IC