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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, including 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 disciplineMinimum experience: 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