Retro

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

Redwood City, CA · Senior

Sponsorship not specified$160k-$195kDetected 19 days ago

Data AnalysisExcelGMPCRISPRFlow CytometryExperimental DesignCommunicationCollaborationAdaptability

About the role

You communicate clearly, ask good questions, and enjoy partnering across teams to turn complex data into shared understanding and practical decisions.
Help establish best practices for characterization method development, data analysis, and documentation, raising the bar for scientific rigor across the analytical team.

You take ownership of your work, think carefully about experimental design, and hold a high bar for data quality, documentation, and interpretation.
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.
Partner with AD, QC, and QA scientists and associates to connect characterization insights to QC method development and provide technical guidance where relevant.

You are a rigorous, hands-on scientist who enjoys bringing structure and clarity to complex biological systems.
Have 5+ years of industry experience in analytical development, analytical characterization, or product characterization for biologics, cell therapy, or gene therapy drug products.

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

This listing is sourced directly from Retro's careers page and normalized into a canonical job model.