Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Verte[...]

General Summary The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, provides scientific and technical expertise for late-stage and commercial methods and vendor management. Manages the method life cycle (remediation, validation, transfer, troubleshooting, investigations for OOT/OOS) and data trending analysis. Partners with stakeholders and contract testing sites to ensure cGMP and Quality Management compliance. Key Duties And Responsibilities Lead analytical method remediation, validation, and transfer for separation methods for late-stage and commercial biologics. Lead and support troubleshooting and investigations for in-process, release, and stability testing. Own quality events and analytical activities (Change Controls, Impact Assessments, Change Actions) related to analytical methods. Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and product lifecycle. Ensure on-time deliverables and accountability for project success. Support IND/BLA regulatory submissions and inquiries as analytical method SME. Author technical documents (method SOPs, validation/transfer protocols and reports, bridging, risk assessments). Work with CMO/CTO/external partners on work requests, product characterization, and technology transfers. Review method trending data and prepare APQRs. Knowledge And Skills Expertise in analytical method development/validation/transfer/lifecycle management for protein-based biologics. Hands-on separation methods: chromatography (various modes), electrophoretic (CE, IEF), and/or impurity methods (biologics). Familiar with GMP, CLP, ICH, USP/EP/JP as applicable; proficiency with potency assay regulatory requirements for filings. Statistical tools knowledge (e.g., JMP) desired. Excellent technical communication and writing; ability to manage multiple priorities and timelines. Education And Experience PhD/Master’s/Bachelor’s in biochemistry, chemical engineering, or related field. Typically: PhD + 5+ years; Master’s + 8+ years; Bachelor’s + 10+ years relevant experience. Pay Range $138,400 - $207,600 #J-18808-Ljbffr Scorpion Therapeutics