Quality Control Chemist

hace 3 semanas


Madrid, Madrid, España Moderna A tiempo completo
About Moderna

Moderna is a pioneering biotechnology company that's revolutionizing medicine through mRNA technology. Since our founding in 2010, we've aspired to build the leading mRNA technology platform and create a world-class team.

We're committed to giving our people a platform to change medicine and make a significant impact on patients' lives worldwide.

The Role

This role offers the unique opportunity to join Moderna's Quality Control team based in Madrid, Spain, reporting to the Quality Control Manager. You'll be responsible for performing cGMP QC testing for QC Chemistry, release, and stability programs.

You'll also support global GMP stability programs, including activities such as stability sample set down, pull, and sample shipment/receipt.

In addition, you'll 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.

Your Key Responsibilities:
  • 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.
Requirements:

To succeed in this role, you'll need:

  • Bachelor's degree in Chemistry (or relevant scientific discipline) with at least 5-7 years of experience 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 (Particle Analysis by Dynamic Light Scattering), titrations techniques, and others.
  • Experience with stability testing and related activities, including maintaining stability databases, trending, and statistical analyses, creation, revision, review, and approval of SOPs, stability protocols, and reports according to current GMP, FDA, EU, and ICH guidelines and regulations.
  • 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.
What We Offer:

We offer a competitive salary ranging from $90,000 to $120,000 per year, depending on experience.

Our benefits package includes medical, dental, and vision insurance, 401(k) matching, paid time off, and more.

How to Apply:

Please submit your resume and cover letter to apply for this exciting opportunity.


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