Engineer II, Process Development
Core
Execute late-stage process characterization, technology transfer, and validation readiness for mRNA medicines manufacturing.
Role type
Senior IC process development engineer (biopharma)
Builds
Robust, scalable manufacturing processes for RNA, LNP, and related unit operations
Domain
Biopharma / mRNA therapeutics / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development (late-phase), Process characterization, Bioprocess engineering principles, Process modeling, Design of Experiment (DoE) statistical tools, Experimental execution, Technical documentation, Cross-functional collaboration, Data analysis, Troubleshooting
Preferred skills
Nanoparticle formulations, mRNA manufacturing, Nucleic acid and protein chemistry, Enzyme kinetics, Biotechnology process/product development, AKTA FPLC, Hamilton, Tangential flow filtration (TFF), HPLC/UPLC instrumentation
Responsibilities
Execute late-stage process characterization studies supporting registrational filings, Plan and execute experiments for RNA/LNP unit operations, Develop scale-down models and conduct scale-up studies, Maintain electronic lab notebooks and regulatory-ready documentation, Collaborate with Analytical, Manufacturing, Quality, and Regulatory teams, Present technical results and risks in forums, Identify process gaps and propose data-driven solutions
Seniority
Mid-level, hands-on IC