Senior Scientist
Trident Consulting
Trident Consulting is seeking a \" Sr. Scientist II, Biologics \" for one of our clients in \"Aliso Viejo, CA \" A global leader in business and technology services. Role: Sr. Scientist II, Biologics Key Responsibilities Lead large-molecule analytical & bioanalytical development . Develop, validate, troubleshoot, and transfer analytical methods. Support stability studies, potency, purity, and data trending . Serve as Analytical Lead on CMC projects . Support QC, CRO/CMO activities, and regulatory submissions . Prepare technical reports and regulatory documentation. Provide scientific leadership and mentor junior scientists. Must-Have Skills
HPLC, UPLC, IEX-HPLC, SEC-HPLC, LC-MS
CE, cIEF, MSD, ELISA Method Development / Validation / Transfer Large-molecule analytical development Stability studies & trend analysis GxP / ICH / FDA CMC & regulatory submissions CRO/CMO experience Education & Experience Ph.D. + 8 years OR M.S. + 10 years in Biochemistry, Analytical Chemistry, Immunoanalytical Chemistry, or related field. 6+ years pharmaceutical industry experience in large-molecule analytical development. #J-18808-Ljbffr Trident ConsultingVacancy posted 3 days ago
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