Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell

Overview

Joining Moderna means advancing mRNA science to transform medicine. 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.

• 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 an 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.

• Ph.D. ( 2years experience) or
  
  B.Sc./M.Sc. ( 6years experience) in immunology or a related field conducting assay validation in clinical immunology under GLP/GCLP environment.
• Background in infectious diseases, virology, bacteriology or oncology with experience handling laboratory pathogens at containment level3 (advantage).
• Experience and deep understanding of cell culture and cell based assays, particularly viral neutralization assays or bacteriology assays.
• Strong knowledge of design and execution of efficacy testing in the context of clinical trials.
• Ability to work independently and in a cross functional environment; strong leadership and independence skills expected.
• Excellent written, presentation and interpersonal communication skills; ability to influence and collaborate with internal teams and external stakeholders.
• Curiosity for exploring new technology and boldness in proposing creative experimental designs and ideas.
• Strong computational skills, proficient with Word, Excel, PowerPoint, Graph Pad Prism and other data analysis and statistical software.
• Experience working in a regulated environment with GLP, GCP, ISO standards required.

• Best in class healthcare, plus voluntary benefit programs to support your unique needs.
• Holistic approach to well being with access to fitness, mindfulness and mental health support.
• Family building benefits, including fertility, adoption and surrogacy support.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days and a discretionary year end shutdown.
• Savings and investments to help you plan for the future.
• Location specific perks and extras.

Moderna is committed to equal opportunity in employment and non discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender…