Process Development Associate- Attribute Sciences
Core
Develop and qualify analytical methods (HPLC/UPLC/MS) to characterize therapeutic proteins and support regulatory filings.
Role type
Associate analytical chemist (process development)
Builds
Robust manufacturing processes and analytical methods for biologics
Domain
Biotechnology / Protein Therapeutics
Required skills
HPLC/UPLC method development, Mass Spectrometry, Chromatographic fractionation, Peptide mapping, GMP compliance, Laboratory reporting
Preferred skills
Biochemistry/Analytical Chemistry degree, Method development for therapeutic proteins, Accelerated stability study design
Technologies
HPLC, UPLC, Capillary Electrophoresis, LC-MS
Responsibilities
Perform method development and qualification studies; Conduct chromatographic fractionation and peptide mapping; Author laboratory notebooks and method reports; Maintain GMP environment and instruments; Coordinate attribute identification and characterization studies; Perform accelerated stability studies; Evaluate novel analytical technologies; Support commercial process development and validation.
Seniority
Associate, hands-on IC