Sr Associate Scientist, Analytical Ops

OverviewWe are seeking a highly motivated Senior Associate Scientist to join our Process Impurities Development team within the Method Development and Automation function. This role focuses on the development, optimization, and validation of analytical methods supporting residual impurity testing, host cell protein (HCP) analysis, compendial testing, and raw material characterization to support gene and cell therapy manufacturing.The successful candidate will bring strong experience with ELISA, ELLA, and molecular biology techniques, along with a working knowledge of ICH, USP, and EU regulatory guidelines for analytical method development. You will play a critical role in ensuring product safety and consistency by supporting process development and tech transfer activities across the organization.Title: Sr. Associate Scientist, Process Impurities DevelopmentTeam: Analytical Development, Process Impurities, Method DevelopmentReports to: Principal Scientist, Analytical OpsKey ResponsibilitiesDevelop and optimize analytical methods for detection and quantification of residual impurities, including Host Cell Proteins and nucleic acidsPerform and validate ELISA- and ELLA-based assays for impurity profilingExecute molecular biology methods (e.g., qPCR, ddPCR) to support residual DNA or RNA detectionConduct compendial testing per USP, EP, and other regulatory guidelines for raw materials and in-process componentsDesign and execute method validation studies in accordance with ICH, USP, and EU requirementsTroubleshoot assay performance issues and implement continuous improvementsCollaborate cross-functionally with Process Development, Quality, and Manufacturing teams to integrate analytical methods into development workflowsDocument experimental protocols, validation reports, and supporting SOPs in accordance with GDP and regulatory standardsMaintain compliance with GMP and internal quality systemsBasic QualificationsBA / BS and 4+ years of relevant experience; ORMA / MS and 2+ years of relevant experienceDegree in Biochemistry, Molecular Biology, Analytical Chemistry, or a related disciplinePreferred QualificationsDemonstrated expertise in ELISA, ELLA (e.g., ProteinSimple Ella platform), and quantitative molecular assaysFamiliarity with impurity testing for biologics or gene therapies (e.g., HCP assays, residual DNA/RNA, enzyme activity)Proven experience developing and validating analytical methods in alignment with ICH Q2(R2), USP, and EU guidelinesWorking knowledge of compendial methods and regulatory standards (USP , , , etc.)Proficiency in data analysis using software such as SoftMax Pro, GraphPad Prism, and JMPExcellent technical writing skills for protocols, reports, and submissionsStrong collaborative mindset and communication skillsComfortable working in a dynamic biotech environment with evolving priorities and timelinesCompensation and BenefitsThe salary range for this position is $115,260.00 - $149,160.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.For additional benefits information, visit: Employment OpportunityKite Pharma is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities. For more information, please view the Know Your Rights poster.Additional InformationFor Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047208. Full Time/Part Time: Full-Time. Job Level: Associate. Remote Type: Onsite Required. #J-18808-Ljbffr

Created: 2025-09-17