Cell Therapy Analytical Development (CTAD) Analyst (66356-1)
Posted about 2 months ago
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
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