Research Assoc II, R&D - CPD
Core
Reviewing and overseeing analytical work (method development, validation, technology transfer, stability analysis) for complex injectables like peptides and iron formulations, ensuring GxP compliance and supporting regulatory submissions.
Role type
Senior IC analytical chemist (complex injectables)
Builds
Regulatory-ready analytical data and validated methods for complex drug products
Domain
Healthcare / Pharmaceutical R&D
Required skills
analytical method development, validation, technology transfer, stability analysis, GxP/GDP compliance, regulatory query response, analytical problem-solving, instrument calibration, risk assessment, vendor approval management, SOP preparation and review, data recording (ALCOA++), ELN management
Preferred skills
particle size distribution analysis (gel filtration chromatography, light scattering/diffraction), iron form assays (ferrous, ferric, labile iron, chelation), reduction potential and kinetics, chemical analysis of complex injectables, pharmacopoeia and ICH Guidelines knowledge, troubleshooting analytical issues
Technologies
TCU, Trackwise, ELN, gel filtration chromatography, light scattering/diffraction/obscuration methods
Responsibilities
Plan and perform sample analysis for regulatory submissions; monitor peers and advance studies; plan testing of complex injectable samples (API, development, validation, stability); prepare and review analytical reports, SOPs, and MOAs; manage preventive and breakdown maintenance; investigate failures, deviations, OOT/OOS, and non-compliance; verify chemical/reagent shelf life and resources; review stability programs and vendor DMFs; report daily work status and issues to management
Seniority
Senior, hands-on IC
