Senior Specialist, Raw Material Analytical Characterization
Core
Lead analytical characterization and risk assessment of raw materials (cell culture media, feeds, excipients) used in biologics manufacturing to ensure product quality and supply continuity.
Role type
Senior Specialist, Raw Material Analytical Characterization
Builds
Robust manufacturing processes and reliable supply chains for biologics drug substances
Domain
Biopharmaceuticals / Analytical Chemistry / Bioprocessing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry, Materials characterization, Bioprocessing, Risk assessment, Critical Material Attributes (CMA) identification, Compendial methods (USP/EP/JP/BP), Data interpretation, Cross-functional project management, Technical transfer
Preferred skills
Biologics manufacturing, Cell culture, Fermentation, Chromatographic techniques (HPLC/UPLC/LC-MS), Mass spectrometry, Particle characterization, Thermal analysis, Supplier qualification, PAT, Digital tools
Technologies
HPLC, UPLC, UHPLC, LC-MS, LC-MS/MS, GC-MS, ICP-MS, Microscopy, Thermal analysis
Responsibilities
Develop raw material characterization programs and strategies; Identify and assess Critical Material Attributes (CMAs); Investigate sources of raw material variation; Apply risk-based approaches to prioritize materials; Support qualification of new materials and suppliers; Develop analytical methods for impurity and contaminant identification; Collaborate with Manufacturing, Quality, and Regulatory teams; Support regulatory filings and GMP compliance
Seniority
Senior, hands-on IC
