Descripción de la oferta
Mantell Associates is currently supporting a global biopharmaceutical organisation based in León, specialising in the development, manufacturing, and commercialisation of biosimilars, alongside offering integrated CDMO services worldwide.With continued investment driving growth, they are looking to expand their Quality Control team with an experienced QC Consultant specialising in biological methods. This is a fully onsite role within a GMP-regulated laboratory environment.QC Consultant - Responsibilities:
Perform biological and immunochemical testing (e.g. potency assays, bioassays, ELISA) in line with GMP requirements
Support method validation, transfer, and lifecycle management of analytical methods
Lead and manage deviations, OOS and OOT investigations, including root cause analysis and CAPA implementation
Prepare and review validation protocols, reports, and technical documentation
Support stability studies and characterisation of reference materials
Manage QC documentation, including SOPs, specifications, and change controls
Contribute to laboratory organisation and coordination within the potency & contaminants teamQC Consultant - Requirements:
Strong experience in biological QC / bioassays / potency testing
Hands-on expertise with ELISA, cell-based assays, or immunoassays
Proven experience in GMP environments
Solid background in method validation and investigations (OOS/OOT)
Fluent Spanish and good level of English
Minimum 3+ years’ experience in a similar QC roleWhat’s on Offer:
Opportunity to join a high-growth, investment-backed CDMO
Exposure to advanced biopharmaceutical products (biosimilars)
Collaborative, project-driven environment with strong pipeline
Competitive daily rate, reflective of the technical expertise requiredMantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
