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Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based

External
Moderna logoModerna · Oxford -, UK
Full-timeOn-siteToday
Clinical TrialsComplianceData AnalysisDocumentationGCPLeadership
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About the role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. At Harwell, you will play a critical role in advancing Moderna's clinical development programs by leading the development, qualification, validation, and execution of complex cell-based immunoassays that generate high-quality data to support clinical trials across multiple therapeutic areas. Working at the intersection of immunology, assay science, and clinical development, you will serve as a scientific point of contact within the Immuno-assays group, driving assay excellence while collaborating across multidisciplinary teams and external partners. This is an opportunity to apply deep technical expertise while helping shape innovative approaches, technologies, and data generation strategies that support Moderna's growing pipeline and future platform capabilities, including increasing exposure to advanced digital and AI-enabled scientific workflows. Here's What You'll Do: Serve as a scientific point of contact for cell-based immunoassay development activities supporting clinical programs across multiple therapeutic areas. Be responsible for the quality and integrity of assigned projects supporting Moderna clinical trials. Design, develop, optimize, and execute cell-based immunoassays to support clinical development objectives. Lead assay qualification and validation activities to ensure assays meet scientific, regulatory, and operational requirements. Perform clinical sample testing and analysis, generating robust, reproducible, and high-quality datasets. Conduct testing and data analysis in compliance with applicable GCP and GLP requirements. Deliver high-quality data within established timelines and in alignment with current industry expectations and standards. Perform data acquisition and analysis on clinical specimens and communicate findings effectively to stakeholders. Author technical reports, validation reports, study documentation, and supporting scientific materials. Identify, investigate, and resolve quality-related issues, escalating concerns to management when appropriate. Serve as a Subject Matter Expert (SME) on multifunctional project teams as needed. Represent the Immunoassay Team at project meetings, presenting assay results, data interpretation, development progress, timelines, and recommendations. Collaborate with internal colleagues and external partners to evaluate emerging technologies, novel methodologies, and innovative solutions that address complex scientific challenges. Maintain broad knowledge of industry best practices in cell culture, immunoassay development, assay validation, and clinical sample analysis. Stay informed on new technologies, platforms, critical reagents, and scientific advancements relevant to immunoassay development and execution. Support continuous improvement initiatives that enhance assay performance, laboratory efficiency, data quality, and scientific rigor. Coach and train junior laboratory staff on assay execution, technical procedures, best practices, and compliance requirements. Provide constructive input regarding the strengths, development opportunities, and performance of assigned junior associates. Contribute to periodic performance review discussions for junior team members. Foster a collaborative and inclusive laboratory environment that supports knowledge sharing and scientific excellence. Ensure ongoing compliance with safety, quality, regulatory, and laboratory guidelines at all times. Maintain accurate and up-to-date training records and documentation. Support operational needs that may occasionally require overtime work or weekend coverage. Travel as required to attend training programs, technical conferences, scientific meetings, and industry exhibitions. Report directly to the Associate Director, Immuno-assay UK. The key Moderna Mindsets you'll need to succeed in the role: We obsess over learning. We don't have to be the smartest, we have to learn the fastest. We behave like owners. The solutions we're building go beyond any job description. Here's What You'll Need (Basic Qualifications) Ph.D. > 2 yrs or BSC/MSc with >6 years' experience in immunology, or related field conducting assay validation in clinical Immunology under GLP/GCLP environment. A background in infectious diseases, virology, bacteriology or oncology and experience with handling laboratory pathogens as containment level 3 is an advantage. Experience and deep understanding of cell culture and cell-based assays, particularly viral neutralization assays or bacteriology assays. Strong level of understanding and expertise in design and executing efficacy testing in the context of clinical trial The ability to work in a cross-functional work environment is critical; strong leadership skills and independence skills are expected. Excellent written, presenta


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