SOKOL GxP Services

cell therapy

CellTherapyAnalyticalDevelopment(CTAD)Analyst(663561)

Summit, New Jersey, United States CONTRACT
The Brief

“Cell Therapy Analytical Development (CTAD) Analyst (66356-1) at SOKOL GxP Services. Skills: analytical testing, method transfer, process characterization, GLP, GMP. Perform analytical experiments. Execute GLP analytical testing to support process characterization activities”

What You'll Achieve.

support analytical testing and method transfer activities; support process characterization testing for lentiviral vector and cell therapy drug product samples; Analyze, summarize, and report experimental data accurately and compliantly

Industry & Context.

cell therapy
Problems you'll solve

analytical skills; analytical troubleshooting

Eligibility Requirements

Hands-on laboratory experience in regulated pharmaceutical or biotechnology settings

What They're Looking For.

Must Have

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, scientific, analytical, and organizational skills, Ability to work independently and manage multiple priorities in a fast-paced environment, written and verbal communication skills

Nice to Have

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

What You'll Do.

Perform analytical experiments

Execute GLP analytical testing to support process characterization activities

Support analytical method transfer and assay execution

and report experimental data

Maintain laboratory documentation

Support assay qualification/validation and analytical troubleshooting activities

Ensure proper operation and routine maintenance of laboratory equipment

Participate in continuous improvement initiatives

support investigation activities

How You'll Work.

Team & Collaboration

Collaborate cross-functionally with Analytical Development and Quality teams

Communication Scope

written and verbal communication skills

Process & Methodology

manage multiple priorities

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