Senior Research Scientist - Peptide Analysis & Analytical Development
Core
Develop, optimize, and apply advanced analytical methods to characterize peptide drug substances, formulations, and degradation products for regulatory approval and clinical-stage programs.
Role type
Senior Research Scientist (Analytical Chemistry/Peptide Analysis)
Builds
Characterization data, stability profiles, impurity profiles, and CMC regulatory dossiers for peptide therapies.
Domain
Biopharmaceuticals / Peptide Drug Development / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LC-MS/MS, SEC-UV, HPLC-UV/DAD, 2D-LC-MS, CD Spectroscopy, DLS, NMR, forced degradation study design, stability study interpretation, ICH Q3A/Q3B/Q6B/Q1A guidelines, CMC regulatory dossier authoring, cross-functional collaboration
Preferred skills
High-resolution mass spectrometry, SEC-MALS, solid-state characterization, GMP analytical environments, statistical data treatment tools, method transfer to QC/CMOs
Technologies
LC-MS/MS, SEC-UV, HPLC-UV/DAD, 2D-LC-MS, CD Spectroscopy, DLS, NMR, SEC-MALS
Responsibilities
Develop and validate analytical methods for peptide characterization; design and execute stability and forced degradation studies; characterize degradation products and impurities; author and review CMC regulatory sections; support pre-submission meetings; collaborate with formulation and manufacturing teams.
Seniority
Senior, hands-on IC
