Senior Scientist, Analytical Development (Large Molecule)
Core
Lead analytical development and characterization for peptides, antibodies, and bioconjugates to support drug substance and drug product development from preclinical through commercialization.
Role type
Senior Scientist, Analytical Development (Large Molecule)
Builds
Analytical methods for raw materials, in-process materials, intermediates, drug substance, and drug product
Domain
Biopharmaceuticals / Large Molecule Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, optimization, qualification, validation, and transfer; Capillary electrophoresis; iCIEF; LC (RP, SEC, IEX); Mass spectrometry; Peptide mapping; SDS-PAGE; ELISA; cGMP compliance; Regulatory strategy (FDA, EMA, ICH)
Preferred skills
LC-MS; Cell-based potency assays; Glycoprotein/carbohydrate characterization; Process development; Formulation development
Technologies
Capillary electrophoresis, iCIEF, LC (RP, SEC, IEX), Mass spectrometry, SDS-PAGE, ELISA
Responsibilities
Develop, optimize, qualify, validate, and transfer analytical methods; Lead characterization activities for complex modalities; Design, execute, and interpret laboratory studies; Support CMC and regulatory activities; Collaborate on cross-functional project teams; Communicate scientific findings to organizational audiences
Seniority
Senior, hands-on IC
