Senior Scientist
Core
Lead and support process development initiatives and manufacturing operations for mRNA excipients and reagents, focusing on scalable workflows and quality attributes.
Role type
Senior Scientist (mRNA process development)
Builds
mRNA manufacturing processes and scalable workflows
Domain
Biopharmaceuticals / mRNA technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mRNA process development, DNA template generation, in vitro transcription (IVT), enzymatic processing, purification, analytical characterization, DOE, QbD, process characterization, scale-up, risk assessment, CPP/CQA relationships, troubleshooting, data-driven solutions
Preferred skills
End-to-end mRNA development, IVT, capping/polyadenylation, chromatography, TFF/UF-DF, process scale-up, technology transfer, GMP manufacturing support, high-throughput automation, continuous manufacturing, PAT, mRNA analytical techniques (HPLC/UPLC, LC-MS, CE, qPCR/ddPCR, Bioanalyzer/TapeStation, sequencing), statistical tools (JMP, Minitab, Python, R), GMP/GLP environments, regulatory documentation, method qualification, validation, technology transfer, vendor/CDMO evaluation
Technologies
HPLC/UPLC, LC-MS, CE, qPCR/ddPCR, Bioanalyzer, TapeStation, sequencing, JMP, Minitab, Python, R
Responsibilities
Design and optimize end-to-end mRNA manufacturing processes, develop robust scalable workflows, apply DOE/QbD/statistical tools for process understanding, collaborate with analytical development for characterization, troubleshoot process and product-quality challenges, author technical reports and regulatory documentation, evaluate emerging technologies and vendors, support process characterization and control strategy development, participate in deviation investigations and continuous improvement, mentor junior scientists
Seniority
Senior, hands-on IC with mentorship responsibilities
