Principal Research Scientist I, Biologics Analytical Research and Development, CMC Biologics Development
Core
Lead phase-appropriate analytical development strategies for biologics characterization including ADC, PDC, AOC, fusion proteins, and multi-specific antibodies.
Role type
Principal Research Scientist (Biologics Analytical R&D)
Builds
Biotherapeutics extended characterization methods for in-process analytics, batch release/stability, RS qualification, and comparability studies.
Domain
Biopharmaceuticals / Biologics / Analytical Chemistry
Required skills
Mass spectrometry-based characterization (intact/subunit analysis, peptide mapping, disulfide bond mapping), Separation-based analytical techniques (SEC, HIC, HILIC, RPLC, IEX, CE, icIEF), Risk-based analytical development, Method validation, CQAs assessment, Reference standard qualification, Comparability study
Preferred skills
Biophysical assays, Binding and functional assays, Lab automation
Technologies
MS software platforms
Responsibilities
Design and execute buildout of biotherapeutics extended characterization methods; Author, review lab notebooks, analytical reports, and regulatory filing sections; Present at leading scientific conferences; Mentor/supervise a team of one or more
Seniority
Principal, hands-on IC with leadership
