Senior Scientist / Senior Engineer, LNP Process Development
Core
Lead the design, execution, and optimization of lipid nanoparticle (LNP) formulation and drug product manufacturing processes from bench to GLP/GMP scale.
Role type
Senior Scientist / Senior Engineer, LNP Process Development
Builds
Robust, scalable LNP formulation and drug product manufacturing processes for gene editing therapies
Domain
Biotechnology / Gene Editing / LNP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LNP formulation development, Tangential Flow Filtration (TFF) operations, process scale-up, technology transfer, analytical characterization (HPLC/UPLC, DLS/SLS, TEM, DSC, SAXS, UV-Vis, fluorescence spectrophotometry), statistical design of experiments (DoE), Quality by Design (QbD), CMC regulatory knowledge
Preferred skills
Experience with novel materials and delivery innovations, hands-on equipment system setup for LNP/TFF processes
Technologies
HPLC, UPLC, DLS, SLS, TEM, DSC, SAXS, UV-Vis, fluorescence spectrophotometry, ELNs
Responsibilities
Lead design and optimization of LNP processes from bench to GLP/GMP scale; Serve as subject matter expert for LNP process development across programs; Evaluate and implement emerging technologies and process innovations; Support technology transfer activities to external CDMOs; Author and contribute to CMC sections of regulatory filings; Maintain documentation and generate experimental protocols and technical reports
Seniority
Senior, hands-on IC
