Elevatebio Benefits Overview

Develop, optimize, scale, and characterize mRNA production and purification processes. Perform IVT, plasmid DNA linearization, TFF, chromatography, and analytical testing while supporting tech transfer from bench scale to GMP manufacturing. Collaborate with MSAT, analytical development, clients, and business development teams on project execution, proposals, technical communications, SOPs, and regulatory documentation. Preferred experience includes mRNA-LNP formulation, JMP-based DoE, GMP regulations, Quality by Design, and regulatory filings.

Performs routine cGMP manufacturing of cell and gene therapy products, including aseptic processing, cell culture, cryopreservation, fill-finish, batch record review, and visual inspection. Supports SOPs, materials, training, equipment setup, deviations, CAPAs, change controls, and process improvements. Collaborates with Quality, MSAT, engineering, process development, and quality control teams while maintaining high safety and quality standards. Requires flexibility for overtime, weekends, holidays, and physically demanding work.

Provides manufacturing science and technology support for GMP drug-product manufacturing, technology transfers, process development, characterization, validation, troubleshooting, deviation investigations, and continuous improvement. Serves as a technical SME, authors protocols and regulatory documentation, performs process data analysis, supports risk assessments and quality systems, and collaborates with Manufacturing, Quality, Regulatory, Supply Chain, and external clients.