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The RoleModerna is seeking a Senior Research Associate based in Madrid, Spain.
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).
Here's What You'll DoAs part of the Analytical Science & Technology team, your primary responsibilities will be as follows:
Support Analytical Method Acquisitions / Qualification / Validation projects in a fast-paced environment.Author method qualification / validation protocols and reports.Support external transfers of analytical methods.Support efforts for method troubleshooting, remediation, change and optimization efforts in conjunction with Quality Control and Analytical Development.Adhere to method lifecycle (acquisition, qualification/validation, implementation) timelines.Authors Equipment and Method SOPs.Train QC analysts to perform testing.Review of executed assay packages, including review of chromatography data and other analytical outputs.Author and/or support quality systems records such as deviations, change controls, CAPAs.Conduct and/or support technical assessments of deviations and investigations.Maintain a safe laboratory working environment.Other responsibilities as needed.Here's What You'll Bring to the TableMinimum education required: Bachelor's degree in a relevant scientific discipline.
Minimum experience requires:
Bachelor's degree in Sciences and 2-5 years of industry experience in a cGMP laboratory setting focused on analytical chemistry and raw materials pharmacopeia testing.Working knowledge of relevant and current FDA, EU, ICH guidelines, USP/EP/JP pharmacopeias, and regulations.Demonstrated knowledge of method qualifications/validations.Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.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.Fluently (written / spoken) in English.Excellent communication skills (verbal and written).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.
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