SOKOL GxP Services is seeking a motivated Cell Therapy Analytical Development (CTAD) Analyst to support analytical testing and method transfer activities within a fast-paced cell therapy environment.
This role supports process characterization testing for lentiviral vector and cell therapy drug product samples and requires hands-on laboratory experience in regulated pharmaceutical or biotechnology settings.RequirementsPerform analytical experiments using methodologies such as PCR, RT-qPCR, flow cytometry, mammalian cell culture, ELISA, MSD, and LuminexExecute GLP analytical testing to support process characterization activitiesSupport analytical method transfer and assay execution with moderate supervisionAnalyze, summarize, and report experimental data accurately and compliantlyMaintain laboratory documentation in accordance with GLP/GDP requirementsCollaborate cross-functionally with Analytical Development and Quality teamsSupport assay qualification/validation and analytical troubleshooting activitiesEnsure proper operation and routine maintenance of laboratory equipmentParticipate in continuous improvement initiatives and support investigation activities as neededRequired QualificationsBachelor’s degree in Molecular Biology, Cell Biology, Immunology, or related scientific disciplineMinimum 2 years of laboratory experience in pharmaceutical, biotechnology, or cell therapy environmentsHands-on experience with PCR and/or flow cytometry and/or mammalian cell cultureExperience working in a GLP/GMP-regulated environmentStrong scientific, analytical, and organizational skillsAbility to work independently and manage multiple priorities in a fast-paced environmentStrong written and verbal communication skillsPreferred QualificationsExperience with assay development or assay qualification/validationCell-based potency assay experienceExperience supporting analytical technology transfer activitiesFamiliarity with lentiviral vector or cell therapy productsBenefitsCompetitive hourly rate: $44.50 – $48.10/hr (W-2 only, no C2C) Working Hours: Monday - Friday, regular business hours12-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefitsEmployee referral bonus program