Research Scientist - Cell Potency Validation Join to apply for the Research Scientist - Cell Potency Validation role at Thermo Fisher Scientific . This role involves working independently or with partners in analytical activities such as method development, validation, and transfer. You will author and review technical documents, serve as a Subject Matter Expert (SME), troubleshoot issues, and participate in meetings. Key Responsibilities: Perform analytical lifecycle activities including method development, validation, and transfer. Author and review technical documents like SOPs, study protocols, and reports. Act as SME for troubleshooting and investigations during release and stability testing. Assess deviations, CAPAs, and change controls. Participate in internal and external meetings. Education and Experience: Bachelor's degree in Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or related field. ARS (Assoc Research Scientist): 6+ years' experience. Master's degree with 4+ years' experience or PhD with 2+ years' experience. Knowledge, Skills, and Abilities: Excellent technical writing skills. Hands-on experience with cell-based potency assays, biochemistry, cell biology, immunoassays, molecular assays. Knowledge of gene and cell therapy is a plus. Understanding of ICH, regulatory guidelines, and GMP. Experience with analytical support for biological products and cGMP manufacturing. Ability to prioritize and manage multiple projects effectively. Proficiency with statistical tools like JMP is a plus. Working Environment: Ability to communicate effectively, work in various environments, lift objects up to 25 pounds, and perform under pressure. May involve exposure to hazardous elements in healthcare or lab settings. Benefits: Competitive salary, bonuses, healthcare, and career development opportunities, within a culture of integrity, innovation, and involvement. #J-18808-Ljbffr Thermo Fisher Scientific
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