This role involves ensuring the quality and regulatory compliance of Moderna's mRNA medicines through analytical chemistry testing within their Madrid analytical excellence center. The specialist will conduct cGMP QC testing for release and stability, support method transfers, and contribute to the troubleshooting and qualification of methods and equipment. It's a highly technical position focused on laboratory excellence, supporting junior team members, and maintaining data integrity and documentation in a fast-paced biotech environment.
Perform routine analytical chemistry testing including HPLC, UPLC, UV, particle analysis, and dynamic light scattering.
Execute and support stability studies and GMP release testing.
Manage LIMS (LabVantage) sample result entries and electronic assay forms.
Assist with method transfers and development activities within QC Chemistry.
Support special projects and initiatives for QC laboratory optimization and compliance.
Perform general laboratory operations such as sample management, reagent preparation, equipment maintenance, and lab housekeeping.
Complete and maintain cGMP documentation, ensuring full data integrity compliance.
Write and revise SOPs, protocols, and reports in accordance with internal and external requirements.
Contribute to training and troubleshooting activities for junior staff.
Participate in investigations, deviations, change controls, and CAPAs within quality systems.
Support overall lab readiness and supply stocking to ensure uninterrupted QC operations.
Create a safe working environment and comply with all GxP and company standards.
Bachelor's Degree (BA/BS) in Chemistry (preferred) or other relevant scientific discipline; undergraduate program students are acceptable.
2-5 years of working experience in a quality control laboratory of a pharmaceutical company.
Hands-on experience with analytical chemistry testing, including chromatographic techniques (HPLC, UPLC), spectroscopic and spectrometric techniques, and physical properties techniques such as Particle Analysis by Dynamic Light Scattering.
Working experience in a GMP environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations (preferred).
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Bachelor's Degree
Must work on-site full-time at Moderna's Madrid facility.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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