Scientist/Senior Scientist, Analytical Development & Characterization – Cell Therapy

Own elements of the analytical characterization strategy for intermediates and drug products, defining what needs to be measured, why, and how, to establish product and process understanding in support of the IND.

Design and execute non-GMP flow cytometry and functional characterization methods to evaluate product-related impurities, variants, and MoA-reflective measures of biological activity.

Design and execute IND-enabling characterization studies, including drug product stability (shelf-life, shipping, and in-use conditions), justification of the QC vial as a surrogate for the DP vial, and material compatibility of the DP vial and administration catheter with the drug product.

Develop, optimize, and performance-evaluate characterization methods to ensure they are scientifically sound and fit for purpose, documenting outcomes in protocols and reports.

Interpret and communicate characterization data to support CQA definition, specification setting, and regulatory justification in collaboration with the team and Head of Quality & Analytical.

Help establish best practices for characterization method development, data analysis, and documentation, raising the bar for scientific rigor across the analytical team.

Partner with AD, QC, and QA scientists and associates to connect characterization insights to QC method development and provide technical guidance where relevant.

Contribute characterization data and authored sections to IND and other regulatory submissions, ensuring accurate representation of the product and process understanding package.

Have 5+ years of industry experience in analytical development, analytical characterization, or product characterization for biologics, cell therapy, or gene therapy drug products.

Bring hands-on expertise in flow cytometry method development and data analysis, including multiparameter panel design, assay optimization, instrument QC considerations, and characterization of product-related attributes.

Have experience developing, optimizing, troubleshooting, or applying functional assays, potency-adjacent assays, or MoA-reflective biological activity assays.

Are comfortable designing and executing characterization studies and interpreting results in the context of product understanding, method performance, specification-setting, or regulatory filings.

Have experience working independently, prioritizing across multiple studies, and producing high-quality scientific documentation, including protocols, reports, and data packages.

Are familiar with phase-appropriate regulatory expectations for analytical characterization in support of IND submissions.

Hold an advanced degree, PhD preferred or MS with substantial industry experience, in cell biology, biochemistry, immunology, analytical sciences, or a related life science discipline.

Have experience with iPSC-derived cell therapy products, including microglia, hematopoietic stem/progenitor cells, immune cells, or other complex cell-based products.

Have experience designing or executing drug product stability studies, including shelf-life, shipping, and in-use conditions.

Have experience with QC vial surrogate justification, material compatibility, container closure, administration materials, or extractables/leachables-related studies.

Have supported or authored characterization sections of CTD Module 3 regulatory submissions.

Are familiar with relevant regulatory guidance, including ICH Q6B, ICH Q5C, and related expectations for biologics or cell therapy product characterization.

Have worked in a startup or resource-constrained environment where scientific independence, adaptability, and strong judgment were essential.