Cell Therapy Analytical Development (CTAD) Analyst (66356-1)
12 days ago
Summit
Job Description 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. Requirements • Perform analytical experiments using methodologies such as PCR, RT-qPCR, flow cytometry, mammalian cell culture, ELISA, MSD, and Luminex, • Execute GLP analytical testing to support process characterization activities, • Support analytical method transfer and assay execution with moderate supervision, • Analyze, summarize, and report experimental data accurately and compliantly, • Maintain laboratory documentation in accordance with GLP/GDP requirements, • Collaborate cross-functionally with Analytical Development and Quality teams, • Support assay qualification/validation and analytical troubleshooting activities, • Ensure proper operation and routine maintenance of laboratory equipment, • Participate in continuous improvement initiatives and support investigation activities as neededRequired Qualifications, • Bachelor’s degree in Molecular Biology, Cell Biology, Immunology, or related scientific discipline, • Minimum 2 years of laboratory experience in pharmaceutical, biotechnology, or cell therapy environments, • Hands-on experience with PCR and/or flow cytometry and/or mammalian cell culture, • Experience working in a GLP/GMP-regulated environment, • Strong scientific, analytical, and organizational skills, • Ability to work independently and manage multiple priorities in a fast-paced environment, • Strong written and verbal communication skillsPreferred Qualifications, • Experience with assay development or assay qualification/validation, • Cell-based potency assay experience, • Experience supporting analytical technology transfer activities, • Familiarity with lentiviral vector or cell therapy products Benefits Competitive hourly rate: $44.50 – $48.10/hr (W-2 only, no C2C) Working Hours: Monday - Friday, regular business hours 12-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits Employee referral bonus program