Senior Scientist - Downstream Process Development, mRNA

Senior Scientist - Downstream Process Development, mRNA role focuses on leading and supporting development, optimization, and process characterization of mRNA downstream manufacturing processes, spanning IVT reactions, purification workflows, and analytical characterization. Scopes include creating scale-down models and DOE studies for process characterization, defining control strategies (CPPs, CQAs, IPCs) for mRNA DS, applying QbD principles and statistical tools for PPQ readiness, and ensuring compliance with FDA/EMA/ICH guidelines. Responsibilities include writing and reviewing method validation/qualification strategies, collaborating with analytical teams, establishing SOPs for mRNA synthesis and purification, and participating in tech transfer to GMP sites; mentoring junior staff and contributing to process transfer and scale-up activities. The role emphasizes hands-on process development, chromatography and filtration knowledge, GDP, aseptic technique, and end-to-end documentation, with potential support for related protein modalities and cross-functional collaboration across GMP environments.