Specialist, Quality Control - Chemistry & Stability

Moderna

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 Do

Your 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.

Here’s What You’ll Need (Minimum Qualifications)

BA/BSc in Chemistry (preferred) or other relevant scientific discipline.
Working experience: at least 5-7 years in quality control laboratory of a pharmaceutical company.
Hands on experience with analytical chemistry testing including chromatographic techniques- HPLC, UPLC, GC; Spectroscopic and Spectrometric techniques; Physical properties techniques such as Particle Analysis by Dynamic Light Scattering; Titrations techniques and others.
Hands on experience with stability testing and related activities such as: maintaining of stability databases, trending and statistical analyses, creation, revision, review and approval of SOP’s, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations.
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.
This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.