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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 discipline
Minimum 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.
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 benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdownEducational resourcesSavings and investmentsLocation-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 is a smoke-free, alcohol-free and drug-free work environment.
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