Principal Scientist, Analytical Development and QC, Small Molecule
Core
Develop and validate analytical methods for small molecule linker payload intermediates to support oncology drug manufacturing, characterization, and regulatory submissions.
Role type
Principal Scientist, Analytical Development and QC (Small Molecule)
Builds
Production-grade analytical methods and control strategies for small molecule therapeutics
Domain
Biopharmaceuticals / Oncology / Small Molecule Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LC, GC, LC-MSMS, NMR, Karl Fischer, spectroscopy, impurity profiling, degradation studies, cGMP compliance, regulatory document authoring, CDMO oversight, stability program management, root-cause analysis, method transfer, reference standard management
Preferred skills
Linker Payload (LP) product characteristics, conjugate type understanding, antibody-drug conjugate (ADC) experience
Technologies
LC, GC, LC-MSMS, NMR, DVS, Karl Fischer, spectroscopy
Responsibilities
Develop phase-appropriate analytical methods for small molecule linker payload intermediates; Provide technical leadership for method development, qualification, validation, transfer, and lifecycle management; Oversee relationships with external testing labs and CDMOs; Lead investigations of method performance, manufacturing issues, and OOS/OOT results; Author analytical sections of CMC documents and regulatory submissions (IND/CTA, NDA/MAA, CTD); Establish analytical and stability plans, impurity-control approaches, and comparability strategies
Seniority
Principal, hands-on IC with strategic oversight
