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GMP Manufacturing Analyst – Biologics

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Mantell Associates

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Location:
Argentina , Buenos Aires

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

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
  • working knowledge of English

Additional Information:

Job Posted:
March 21, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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