GMP Manufacturing Analyst – Biologics

Mantell Associates is partnered exclusively with a leading global biopharmaceutical company based in Buenos Aires to recruit an experienced GMP Manufacturing Analyst to join their biologics operations team on a consultancy basis.

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.

GMP Manufacturing Analyst – Responsibilities:

• 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

GMP Manufacturing Analyst – 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

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.

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.