Specialist, Quality Control - Chemistry & Stability

Detalles de la oferta

.The RoleJoining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its footprint in Madrid, a city that thrives on creativity and innovation. As a crucial part of our commercial operations outside the United States, our Madrid office focuses on delivering our groundbreaking products to the Spanish market. We're seeking professionals who are ready to contribute to our mission and shape the future of mRNA medicines in Spain.Moderna is seeking a Quality Control Chemistry & Stability Associate II to join our team in Madrid, Spain. Reporting to the Quality Control Manager, you will play a key role in cGMP QC testing, focusing on QC Chemistry, release, and stability activities. You will also contribute to the Global GMP stability programs and provide technical support for data management, protocol development, and regulatory submissions.In this role, you'll perform statistical analyses, ensure compliance with international guidelines, and collaborate on special projects that align with Moderna's cutting-edge mRNA technology and innovative spirit.Here's What You'll DoYour key responsibilities will be:Conducting trending and statistical analyses per ICH guidelines.Creating and managing stability protocols, reports, and GMP stability study documents.Supporting stability chamber maintenance, troubleshooting, and data interpretation.Assisting with regulatory submissions by providing stability data and reports.Managing inventories for GMP stability drug substance and products.Your responsibilities will also include:Coordinating stability pulls, set-downs, and external sample shipments.Participating in Quality Event resolutions, including Deviations, CAPAs, and Change Controls.Supporting stability program continuous improvement initiatives.Compiling metrics for quality management reviews and stability meetings.Contributing to audits, safety compliance, and cross-functional stability team discussions.The key Moderna Mindsets you'll need to succeed in the role:We Obsess Over Learning: In the fast-paced field of mRNA technology, your ability to rapidly learn, adapt, and apply innovative approaches will be essential for refining stability programs and data analysis


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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