Scientist 3, Analytical Development
Core
Lead analytical method development for small molecule, peptide, and amorphous drug products from bench to clinic, ensuring GMP compliance and supporting analytical strategy.
Role type
Senior IC analytical development scientist
Builds
Stability-indicating HPLC/UPLC methods, cleaning verification methods, and qualification studies for Quality Control transfer
Domain
Pharmaceutical manufacturing (CDMO), small molecule and peptide drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC/UPLC method development, stability-indicating method design, cleaning verification, method qualification, troubleshooting, data interpretation, SOP creation, lab equipment operation (GC, UV/Vis, DSC, TGA, PXRD, SEM), mentoring
Preferred skills
None stated
Technologies
HPLC, UPLC, GC, UV/Vis spectroscopy, Karl Fischer, DSC, TGA, PXRD, SEM
Responsibilities
Develop stability-indicating methods for APIs and drug products; perform and train others on analytical techniques; troubleshoot and optimize methods; conduct qualification studies; communicate results to clients and internally; create/revise SOPs; supervise 1-2 lab members
Seniority
Senior, hands-on IC with mentoring responsibilities
