Cell Therapy Analytical Development (CTAD) Analyst (66356-1)

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 needed

Required 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 skills

Preferred 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