Mantell Associates
Mantell Associates is partnered with a global biosimilars CDMO, who is seeking a detail-oriented Manufacturing Analyst to join their production team on a contract basis at their Buenos Aires facility.
This opportunity offers the chance to join a globally recognized biosimilars CDMO and play a key role in ensuring production excellence and regulatory compliance within a high-performance manufacturing environment.
Manufacturing Analyst – Responsibilities:
- Support day-to-day production activities and ensure accurate and timely documentation of Batch Records
- Review raw manufacturing data and QC results to confirm compliance with approved manufacturing specifications and GMP standards
- Assist in investigations related to deviations, OOS/OOX events, and non-conformances, ensuring appropriate documentation and follow-up actions
- Collaborate closely with QA and QC teams to maintain GMP compliance across manufacturing processes
- Contribute to the preparation and participation in internal and external audits
- Support continuous improvement initiatives within production operations to enhance efficiency, compliance, and documentation accuracy
- Ensure manufacturing documentation is complete, traceable, and aligned with internal procedures and regulatory requirements
Manufacturing Analyst – Requirements:
- Experience within a biopharmaceutical manufacturing or related production environment
- Strong knowledge of GMP requirements and manufacturing documentation standards
- Demonstrated ability to review and interpret Batch Records, raw data, and QC results
- Excellent organizational skills with strong attention to detail
- Effective communication skills and the ability to collaborate cross-functionally
- Availability to work on-site in Buenos Aires, 5 days per week
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.