Specialist, Quality Control, Bioassay
hace 6 días
The Role Joining 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 within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts. In this individual contributor role, you will play a vital part in the Quality Control (QC) Bioassay team, executing routine cGMP analytical testing for product release and stability programs. You will also support method transfers, method development, and lab-based investigations—ensuring Moderna's high standards for compliance and scientific rigor. This position is essential in ensuring reliable assay performance and data integrity within the QC function in our Madrid site. You will contribute directly to our mission of transforming medicine through mRNA science, while also gaining exposure to digital systems and the potential to work near Generative AI technologies that enhance laboratory and documentation processes. Here’s What You’ll Do Your key responsibilities will be Perform analytical bioassay testing including qPCR, electrophoresis, and sequencing in a cGMP environment. Support method transfers and method development activities aligned with QC standards. Conduct routine sample testing for release and stability, maintaining full regulatory compliance. Utilize LIMS (LabVantage) for result entry and execute Electronic Assay Forms. Write and revise SOPs, protocols, and technical reports as needed. Complete cGMP documentation according to Good Documentation Practices. Participate in the authoring of quality system records such as deviations, investigations, change controls, and CAPAs. Maintain accurate, audit‑ready laboratory records and documentation at all times. Establish and uphold a safe working laboratory environment. Your responsibilities will also include Perform general lab activities such as reagent preparation, equipment maintenance, sample management, and housekeeping. Support junior colleagues with training, troubleshooting, and method familiarization. Manage inventory and QC laboratory supplies to support operational readiness. Assist with equipment and assay troubleshooting as assigned. Contribute to data trending and support special projects when needed. Participate in lab digitalization initiatives with opportunities to work alongside data‑driven platforms and AI‑enabled tools that support laboratory excellence. The key Moderna Mindsets you’ll need to succeed in the role We obsess over learning. We don’t have to be the smartest – we have to learn the fastest.This role demands rapid mastery of evolving QC technologies and methods, and continuous learning to adapt to changes in our mRNA platform and analytical landscape. We digitize everywhere possible using the power of code to maximize our impact on patients. As part of the QC team, you’ll be working with digital platforms like LIMS and other laboratory informatics systems—potentially including exposure to AI‑enabled tools that streamline workflows and enhance data integrity. Embracing digital solutions is core to how Moderna advances its mission. Here’s What You’ll Bring to the Table BA/BS in Biology (preferred) or other relevant scientific discipline with 2-5 years’ experience Working experience: 2-5 years ‘experience in quality control laboratory of a pharmaceutical company Hands‑on experience with bioassay techniques such as Sequencing, qPCR, electrophoresis, etc. 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. This position is site‑based, requiring you to be at Moderna’s site full‑time. This position is not eligible for remote work. At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well‑being resources are designed to support you—at work, at home, and everywhere in between. Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well‑being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation,
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