Chemistry Stability Associate Lead
hace 2 semanas
About the Role
We are seeking a skilled Chemistry Stability Associate II to join our team in Madrid, Spain.
As a key member of our Quality Control Chemistry & Stability team, you will play a vital role in cGMP QC testing, focusing on QC Chemistry, release, and stability activities.
Your responsibilities will include conducting trending and statistical analyses per ICH guidelines, creating and managing stability protocols, reports, and GMP stability study documents.
You will also support stability chamber maintenance, troubleshooting, and data interpretation, as well as assist with regulatory submissions by providing stability data and reports.
In addition, you will manage inventories for GMP stability drug substance and products, coordinate stability pulls, set-downs, and external sample shipments.
Other key responsibilities will include participating in Quality Event resolutions, including Deviations, CAPAs, and Change Controls, and supporting stability program continuous improvement initiatives.
About You
We seek an individual with a BA/BSc in Chemistry or other relevant scientific discipline, with at least 5-7 years of experience in quality control laboratory of a pharmaceutical company.
You should have hands-on experience with analytical chemistry testing, including chromatographic techniques, spectroscopic and spectrometric techniques, physical properties techniques, and titrations techniques.
Experience with stability testing and related activities, such as maintaining stability databases, trending and statistical analyses, creation, revision, review, and approval of SOP's, stability protocols, and reports is also required.
You must have working experience in a GMP environment and knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Able to collaborate effectively in a dynamic, cross-functional matrix environment, efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
About Moderna
At Moderna, we believe in giving our people a platform to change medicine and an opportunity to change the world.
We are a science-driven biotechnology company pioneering messenger RNA (mRNA) technology to create a new generation of transformative medicines.
Our mission is to deliver a new frontier of transformational medicines for patients around the world.
The Benefits
We offer competitive salaries starting at $120,000 annually, plus a range of benefits that support your overall well-being and career growth.
Enjoy comprehensive health insurance, generous paid time off, employee recognition programs, professional development opportunities, and more.
Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
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