Senior Scientist
Core
Establishing and implementing analytical development strategies for RNA therapeutics (raw materials, drug substances, and drug products) to support clinical development.
Role type
Senior Scientist, RNA Analytical Development
Builds
Robust, scalable, and phase-appropriate analytical workflows for nucleic acid medicines
Domain
Biotechnology / Pharmaceutical / RNA Therapeutics
Required skills
Analytical chemistry, LC-MS, LC-HRMS, capillary electrophoresis, chromatography, spectroscopy, QbD principles, CQA definition, SOP development, electronic laboratory management, regulatory documentation, troubleshooting complex technical challenges
Preferred skills
CMC activities, analytical method validation for regulatory submissions, IND-enabling development, modified oligonucleotides, conjugated delivery platforms, automated/high-throughput workflows, purification technologies (preparative chromatography, tangential flow filtration)
Technologies
HPLC, LC-MS, CE, UV spectroscopy, qPCR, DLS, TEM
Responsibilities
Develop analytical characterisation strategies for RNA-related raw materials, drug substances, and drug products; Design and implement analytical workflows using orthogonal techniques; Apply Quality by Design (QbD) principles to establish critical quality attributes (CQAs); Collaborate with process development, formulation, manufacturing, and project teams; Generate, maintain, and review SOPs, analytical methods, validation protocols, and technical documentation; Ensure accurate data capture, management, and traceability through electronic laboratory management systems; Prepare technical reports, presentations, and scientific updates for internal stakeholders; Evaluate and implement emerging analytical technologies and industry best practices
Seniority
Senior, hands-on IC