Scientist Analytical Development / QC Biologics (w/m/d)
Core
Develop, validate, and transfer physico-chemical analytical methods for quality control of biologics; plan, execute, and evaluate stability studies.
Role type
Analytical Development / QC Scientist (Biologics)
Builds
Analytical methods and stability data for biologics products
Domain
Pharmaceutical industry, Biologics
Required skills
physico-chemical analytical method development, method validation, stability study planning and execution, SEC, CEX, CGE, icIEF, Peptide Mapping, GMP documentation, ELN/LIMS systems
Preferred skills
experience in pharmaceutical industry, knowledge of classical pharmacopoeia methods
Technologies
SEC, CEX, CGE, icIEF, Peptide Mapping, ELN, LIMS
Responsibilities
Support laboratory management in method development and validation; Conduct stability studies and analyze data; Ensure method performance throughout the lifecycle; Document work in a regulated GMP environment