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Manager of Analytical Development
A company is looking for a Manager, Analytical Development (Cell Therapy). Key Responsibilities Lead and oversee bioassays, safety assays, and bioanalytical studies, ensuring qualification, validation, and comparability Design analytical runs and investigations, analyze data, and present findings for peer review and regulatory submissions Manage external contracts for analytical method development, product release, and stability testing Required Qualifications, Training, and Education PhD with 2+ years, MS with 5 years, or BS with 7+ years of experience in cell and gene therapy products, focusing on Immunology/Molecular Biology/Genetics Solid understanding of assay verification and validation for clinical and commercial drug product release Experience in quality control and GMP practices Prior experience in developing cell or gene therapy products and familiarity with regulatory guidelines Proficient in project management tools and capable of managing multiple projects in a fast-paced environment
A company is looking for a Manager, Analytical Development (Cell Therapy).
Key Responsibilities
Lead and oversee bioassays, safety assays, and bioanalytical studies, ensuring qualification, validation, and comparability
Design analytical runs and investigations, analyze data, and present findings for peer review and regulatory submissions
Manage external contracts for analytical method development, product release, and stability testing
Required Qualifications, Training, and Education
PhD with 2+ years, MS with 5 years, or BS with 7+ years of experience in cell and gene therapy products, focusing on Immunology/Molecular Biology/Genetics
Solid understanding of assay verification and validation for clinical and commercial drug product release
Experience in quality control and GMP practices
Prior experience in developing cell or gene therapy products and familiarity with regulatory guidelines
Proficient in project management tools and capable of managing multiple projects in a fast-paced environment