Sr. Scientist II, Biologics Onsite in Aliso Viejo

Role: Senior Scientist II in Biologics within the Analytical Technologies team, supporting large molecule drug development from early clinical stages to commercialization. Responsibilities: develop, validate, transfer, and troubleshoot analytical and biological potency assays, including cell-based methods; oversee stability studies and perform trending analysis; serve as analytical lead on CMC project teams; author technical reports and contribute to regulatory submissions such as INDs and NDAs; collaborate with CROs, CMOs, and cross-functional teams; provide training and guidance to colleagues, and support QC method development and validation. Requirements: Ph.D. with 8+ years or M.S. with 10+ years in biochemistry, analytical chemistry, or related field; extensive experience in analytical methods for large molecules, including chromatography, LC-MS, ELISA, ddPCR, qPCR, and protein characterization techniques; proven ability to lead investigations, troubleshoot, interpret stability data, and ensure regulatory compliance within GxP environments. High-Value: expertise in assay technologies for biologics, stability studies, regulatory documentation, and working knowledge of drug development stages; experience with protein engineering collaboration; strong project management skills, capability to work cross-functionally in a regulated setting, and proficiency in analytical troubleshooting and innovation. WorkSetup: based in Aliso Viejo, CA; onsite preferred.