Specialist, Sample Management
Core
Manage the lifecycle of QC samples (Drug Substance, Drug Product, Raw Materials) including processing, storage, stability support, and release for biologics manufacturing.
Role type
QC Sample Management Specialist
Builds
Biologics drug substances and products for patient therapies
Domain
Biopharmaceutical manufacturing / Cell culture biologics
Required skills
GMP compliance, LIMS/CIMS logging, sample storage and handling, stability study support, buffer preparation, SOP generation, deviation reporting, aseptic manufacturing knowledge
Preferred skills
Chemistry/Biology degree, laboratory experience, team collaboration
Technologies
LIMS, CIMS, TempTales, cryogenics logistics systems
Responsibilities
Liaise with manufacturing and warehouse to ensure timely sample delivery; Manage temperature monitoring and shipping documents; Log and label samples; Release samples for QC testing; Support stability study enrollment and timepoint pulls; Reconstitute and aliquot samples; Perform monthly reconciliation and report deviations; Maintain GMP compliance and training.
Seniority
Entry-level to Mid-level, hands-on IC