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This is a hands-on consultancy position, 5 days per week on-site in Buenos Aires, focused on the review and assessment of biological raw data across QC analytical operations. You will play a critical role in ensuring data integrity, regulatory compliance and quality standards are maintained across a complex, fast-paced biologics manufacturing environment. You’ll be joining an organisation at the forefront of biosimilar development in Latin America – one that is genuinely committed to expanding patient access to life-changing treatments globally. This is a high-impact role within a world-class quality function.
Job Responsibility:
Review and assessment of biological raw data across QC analytical operations
Ensuring data integrity, regulatory compliance and quality standards are maintained across a complex, fast-paced biologics manufacturing environment
Requirements:
Proven experience in QC within a biologics or biopharmaceutical environment
Strong background in biological raw data review – including analytical methods such as HPLC, ELISA, cell-based assays, and/or chromatography
Solid understanding of GMP, data integrity principles (ALCOA+), and regulatory expectations (FDA, EMA, or equivalent)
Experience in monoclonal antibody or biosimilar manufacturing is highly advantageous
Ability to work on-site full-time in Buenos Aires
Nice to have:
Experience in monoclonal antibody or biosimilar manufacturing