Research Associate I - R&D, Complex Product Development
Core
Execution of advanced characterization studies for complex injectable drugs including iron formulations, proteins, peptides, and oligonucleotides to support regulatory submissions.
Role type
Research Associate I, analytical characterization
Builds
Analytical data and reports for regulatory submissions
Domain
Biopharmaceuticals / Complex injectables
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SEC-UV-MALS, light scattering, diffraction, light obscuration, liquid chromatography, computational chemistry, molecular modeling, statistical methods, NMR operation, instrument calibration, Good Laboratory Practices, Good Documentation Practices
Preferred skills
CD, FTIR, UV, EPR, Mossbauer, fluorescence spectroscopy, particle XRD, microscopy (AFM & EM), pharmacopoeia knowledge, ICH Guidelines
Technologies
SEC-UV-MALS, NMR, AFM, EM, ELN
Responsibilities
Perform advanced characterization of complex injectable drugs; manage outsourced studies at CROs and external facilities; operate and maintain analytical instruments; prepare method development and verification reports; troubleshoot product development issues; ensure compliance with GLP and ALCOA++ principles.
Seniority
Mid-level, hands-on IC
