Research Associate I - R&D, Complex Product Development
Core
Execution of advanced characterization studies for complex injectables (proteins, peptides, oligonucleotides) to support regulatory submissions and global manufacturing.
Role type
Research Associate I, analytical characterization
Builds
Analytical data and reports for regulatory submissions and product development
Domain
Biopharmaceuticals / Complex injectables
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CD spectroscopy, FTIR, fluorescence spectroscopy, method development, GLP compliance, SOP preparation, instrument calibration, data analysis, literature search, pharmacopoeia knowledge
Preferred skills
computational chemistry, molecular modeling, statistical methods, liquid chromatography, dynamic light scattering, AF4-MALS, SV-AUC, NMR operation
Technologies
CD, FTIR, fluorescence spectroscopy, ELN, NMR, liquid chromatography, AF4-MALS, SV-AUC
Responsibilities
Perform advanced characterization of complex injectable drugs; manage outsourced studies at CROs and external facilities; liaise with cross-functional teams as SME; operate and maintain analytical instruments; prepare method development and verification reports; ensure compliance with GLP and ALCOA++ principles.
Seniority
Mid-level, hands-on IC
