Principal Research Scientist I
Core
Lead process analytics for monoclonal antibodies and drug substances in late-stage biologics clinical programs, serving as a subject matter expert for separation-based methods.
Role type
Principal Research Scientist (Process Analytics)
Builds
Analytical methods and testing results for biologics mAbs and DS process development, characterization, and GMP manufacturing.
Domain
Biopharmaceuticals / Biologics / Process Analytics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, capillary electrophoresis, method development, technical writing, regulatory submissions, risk management, project leadership, troubleshooting
Preferred skills
Late-stage program experience, multi-specifics and ADC expertise, novel analytical technique implementation
Technologies
HPLC, capillary electrophoresis
Responsibilities
Serve as process analytics lead for mAb and DS in CMC teams; act as SME for separation-based methods; evaluate and select analytical technologies; support timely delivery of high-quality testing results; provide expertise in method development, execution, and troubleshooting; review analytical results and communicate risks; collaborate with R&D and PDS&T teams; prepare technical documents for IND/BLA filings; mentor junior scientists.
Seniority
Principal, hands-on IC with mentorship
