Camarillo, CA30+ days ago
Responsibilities: • Perform and review routine in-process, release, and stability testing for biologic drug substances and drug products • Execute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping) • Perform capillary electrophoresis testing (cIEF, CE-SDS) • Perform plate-based ELISA, ligand binding assays • Lead laboratory investigations, including OOS, OOT, and atypical result investigations • Conduct root cause analysis and identify, implement, and verify effectiveness of CAPAs • Draft and oversee protocols for method validation, verification, and transfer • Interpret results, perform statistical analyses, and prepare validation reports aligned to ICH Q2 and US FDA expectations • Author and review SOPs, test methods, protocols, and technical reports • Ensure all work is performed in compliance with cGMP, data integrity principles, and internal QA/QC policies • Support regulatory inspections and audits as a subject matter expert • Maintain departmental instruments and ensure timely execution of QC quality system records • Mentor team members and oversee analytical workflows to meet project goals. D. in Biology, Chemistry, Biochemistry, or a related scientific field • Minimum of 10 years of direct, hands-on experience in a GMP Quality Control laboratory supporting biologics • Deep technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing • Strong background in laboratory investigations, OOS management, and CAPA implementation • Hands-on experience with method validation aligned to ICH Q2 and US FDA regulations • Excellent technical writing, documentation, and analytical troubleshooting skills • Ability to work independently while collaborating effectively across QC, QA, and Manufacturing • Experience in a commercial-stage or late-phase biologics environment is preferred • Familiarity with LIMS and chromatography data systems (e.g., Chromeleon) is highly desirable • Strong familiarity with GxP • Excellent communication, interpersonal, and organizational skills are required.