Analytical Research Associate

Job Summary:We are seeking a Research Associate to join the Analytical Development team supporting the characterization and testing of complex biologics. This hands-on, on-site laboratory role involves the development, validation, and execution of analytical methods for drug substances and drug products across clinical and commercial phases. The ideal candidate will collaborate cross-functionally to provide analytical expertise for product development, process optimization, and regulatory support.Responsibilities:Develop, validate, and execute analytical methods to support biologics development.Operate, maintain, and oversee installation of complex analytical instrumentation (e.g., LC/MS, CE-SDS).Author and review technical documents, including protocols, reports, SOPs, and change controls.Lead and contribute to scientific initiatives and technical projects.Collaborate with cross-functional teams including Process Development, R&D, and QC.Support laboratory operations including inventory management, reagent preparation, and documentation.Ensure compliance with applicable regulatory guidelines (ICH, GMP, GLP, GCP, GDP).Qualifications:Master's degree in biological sciences or related field with 5+ years, or PhD with 2+ years of industry experience (post-doc may be considered).Proficient in analytical techniques: absorbance assays, chromatography, LC/MS, CE-SDS, ELISA, western blot.Experience with characterization tools such as AUC, DLS, MFI, and CD.Skilled in drafting protocols, methods, and SOPs.Familiar with GxP practices and global regulatory requirements.Knowledge of statistical tools (e.g., R, Python) is preferred.Expertise in Liquid Chromatography and LC/MS.Background in neurotoxin therapeutics.

Created: 2025-10-01