• To be considered for this role, your application (CV / resume) must be submitted in English, as this is our internal business language. If you have knowledge of additional languages, that is very advantageous - but any applications which are not in English, these will not be considered. Many thanks!*
• Para ser considerado para este puesto, su solicitud (CV/currículum vitae) debe presentarse en inglés, ya que es nuestro idioma comercial interno. Si tiene conocimientos de otros idiomas, es muy ventajoso, pero las solicitudes que no estén en inglés no se tendrán en cuenta. Muchas gracias!*
  
  

The Role:

Moderna is seeking a Senior Research Associate, Analytical Science & Technology – Bioassay Operations based at Madrid. The individual in this role will focus on support of Analytical Chemistry Tech Transfer activities including method lifecycle projects (Acquisition, Qualification / Validation, Optimization and Troubleshooting). The individual will coordinate across teams to meet business objectives and may support daily QC operations as needed.

The role is focused on cell-based ELISA and in vitro potency assays method transfer, qualification, and validation activities.

Here’s What You’ll Do:

• As part of the Analytical Science & Technology team, your primary responsibilities will be as follows:
• Support and lead Analytical Method Acquisitions / Qualification / Validation projects in a fast-paced environment.
• Author method qualification / validation protocols and reports.
• Author method qualification and validation master plans.
• Author method qualification and validation summaries for regulatory submissions.
• Support external transfers of analytical methods.
• Support efforts for method troubleshooting, remediation, change and optimization efforts in conjunction with Quality Control and Analytical Development.
• Monitor and communicate method lifecycle (acquisition, qualification / validation, implementation) timelines using project management tools.
• Authors Equipment and Method SOPs.
• Train QC analysts to perform testing.
• Lead Reviewer of executed assay packages. Includes review of data and other analytical outputs.
• Author and/or support quality systems records such as deviations, change controls, CAPAs. Conduct technical assessments of deviations and investigations
• Support responses to compliance audits.
• Maintain a safe laboratory working environment
• Other responsibilities as needed.
  
  
  

Here’s What You’ll Bring to the Table:

• Minimum education required: Bachelor’s degree in a relevant scientific discipline
• Minimum education: Bachelor’s degree in sciences and a minimum of 4 years (or MS in a relevant scientific discipline with 2 years) with a focus in Mammalian Cell Culture, sequencing, and potency assays.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
• Knowledge and hands-on experience performing and troubleshooting potency assays.
• Demonstrated knowledge of method qualifications/validations.
• Excellent troubleshooting and ability to communicate issues in a scientifically sound way.
• Proven ability to conduct investigations.
• Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Excellent communication skills (verbal and written).
• Fluently (written / spoken) in English.
  
  

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• 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, bank holidays, volunteer days, sabbatical, and a discretionary winter break
• Educational resources
• Savings and investments
• Location-specific perks and extras!
  
  

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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