Senior Scientist - SEC / iCIEF / Impurity
Core
Senior Scientist supporting technical transfer, validation, and lifecycle management of biologics separation methods and impurity assays.
Role type
Senior Scientist (Analytical Chemistry/Biologics)
Builds
Analytical methods and data for biologics and cell/gene therapy products
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical method development, validation, and transfer; Biologics and cell/gene therapy product knowledge; HPLC/UPLC, capillary electrophoresis, icIEF, SEC, peptide mapping; GMP compliance (ICH, USP, Ph. Eur., FDA); Technical writing and regulatory documentation
Preferred skills
Statistical tools (JMP); Reference material qualification and stability testing; Inventory management; Quality systems (change control, deviations, CAPA)
Technologies
HPLC, UPLC, Capillary Electrophoresis, icIEF, SEC, Peptide Mapping, JMP
Responsibilities
Support technical transfer, implementation, validation, and lifecycle activities for biologics separation methods; Author, review, and approve technical protocols, reports, and lifecycle documentation; Develop transfer study designs, testing plans, and acceptance criteria; Manage planning and shipment of critical analytical reagents and materials; Support laboratory investigations, deviations, CAPAs, OOS/OOT assessments, and risk assessments; Provide analytical content for regulatory submissions and inspection readiness
Seniority
Senior, hands-on IC
