Senior Analytical Scientist

3 days ago


Tampa, Florida, United States Iovance Biotherapeutics Inc Full time
About the Role: As a Senior Analytical Scientist at Iovance Biotherapeutics Inc, you will play a key role in leading and supporting analytical development potency assay qualification and GXP early-stage assay development projects. The ideal candidate will have relevant experience in analytical method development following GMP and ICH guidelines and proficient technical training in functional cellular and ligand-binding potency assays.

The successful candidate will be responsible for providing scientific input for the design of cell-mediated immunoassays (CMI) regulated studies, selecting appropriate assay formats based on risk assessment and fit-for-purpose, and developing, qualifying, and validating methods. They will also assess and implement new technologies for CMI assays, serve as an internal subject matter expert on developed assays, and ensure that assays are developed and executed per applicable guidance and regulations.

As a member of our team, you will contribute to regulatory filings pertaining to assay details, analyze and interpret experimental data, and present results effectively to stakeholders and within a multi-disciplinary team environment. You will also provide technical leadership and scheduling for the team, maintain up-to-date training and knowledge on automation and analytical tools/equipment, and perform robust analysis and statistical data evaluation for results-driven presentation and cross-functional discussion.

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