.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 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 role, you will work as part of the Quality Control team based in Madrid, Spain, reporting to the Quality Control Manager.
You will be responsible for performing cGMP QC testing for QC Chemistry, release, and stability programs.
You will also support global GMP stability programs, including activities such as stability sample set down, pull, and sample shipment/receipt.
In addition, you will maintain stability databases, perform data trending and statistical analysis, and contribute to the creation, revision, and review of SOPs, protocols, and reports according to GMP, FDA, EU, and ICH guidelines.
This role will provide opportunities to engage in special projects, continuous improvement initiatives, and participate in audits as needed.
Here's What You'll Do Your key responsibilities will be: Performing statistical analysis and trending of stability data following SOPs and ICH guidelines.
Creating, reviewing, and revising stability protocols and reports, including specification documents.
Managing stability studies in LIMS, performing data entry and review as necessary.
Supporting stability chamber maintenance, troubleshooting, and temperature data interpretation.
Your responsibilities will also include: Ensuring the organization and maintenance of stability chambers and walk-ins.
Assisting in the shipment and receipt of samples for external testing or storage.
Managing GMP stability schedules and sample pulls to meet deadlines.
Participating in audits and contributing to regulatory submissions and reports.
Engaging in the continuous improvement of stability programs and compiling relevant metrics.
Supporting reference standard and cell bank stability programs and ensuring compliance with cGMP and safety standards