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This is a technically demanding role that requires genuine hands-on manufacturing experience. Our client is looking for someone who has worked directly within large-scale biological production and can apply that deep process understanding to the critical technical review of batch records and manufacturing documentation – this is not a purely administrative function. As GMP Manufacturing Analyst, you will be responsible for the technical review of batch records and process documentation across large-scale biological manufacturing operations. Your first-hand knowledge of upstream and downstream bioprocessing will be essential in identifying discrepancies, ensuring GMP compliance and maintaining the integrity of the manufacturing record. You will be joining a world-class biologics organisation at the forefront of biosimilar development, playing a direct role in ensuring the quality and compliance of medicines reaching patients across Latin America, Europe and beyond. This is a high-impact position for a manufacturing professional who wants to apply their production expertise in a meaningful and technically challenging capacity.
Job Responsibility:
Technical review of GMP batch records across large-scale biological manufacturing, covering upstream (cell culture, bioreactor operations) and downstream (purification, chromatography, filtration, formulation) processes
Identification, documentation and escalation of batch record discrepancies, incomplete entries and deviations, informed by a genuine understanding of the production process
Ensuring all manufacturing documentation meets GMP requirements, internal quality standards and regulatory expectations
Collaborating with manufacturing, QA and process development teams to resolve documentation issues efficiently
Contributing to the continuous improvement of batch record templates, documentation workflows and best practices
Requirements:
Direct, hands-on experience working in large-scale biological manufacturing – floor-level production experience is essential
Strong technical knowledge of upstream and/or downstream bioprocessing at scale (500L bioreactor capacity or above)
Proven experience in the technical review of GMP batch records or manufacturing process documentation
Solid understanding of deviation management and discrepancy investigation processes
Experience within monoclonal antibody or biosimilar manufacturing highly desirable
Working knowledge of GMP principles and relevant regulatory frameworks (FDA, EMA, ANMAT or equivalent)
Ability to review documentation with a critical, process-informed eye – not simply a compliance checklist approach
Fluency in Spanish
working knowledge of English advantageous
Based in Buenos Aires with full-time on-site availability and able to work on a consultancy basis
Nice to have:
Experience within monoclonal antibody or biosimilar manufacturing