ScientistSenior Scientist, Analytical Development & Characterization – Cell Therapy

We are seeking a new member of the Analytical Development team to drive hands-on non-GMP analytical characterization studies for our iPSC-derived cell therapy products including microglia and hematopoietic stem/progenitor cell this role you will design and execute characterization studies for intermediates and drug product with a focus on flow cytometry functional assays product-related impurities and variants MoA-reflective biological activity and IND-enabling product understanding. Your work will support QC method development CQA definition specification-setting regulatory submissions and long-term control strategy. You will report to the Head of Quality & Analytical and work closely with AD QC QA and regulatory partners.

You are a rigorous hands-on scientist who enjoys bringing structure and clarity to complex biological systems. You are energized by building something new especially when the path is not fully defined and good scientific judgment matters. You take ownership of your work think carefully about experimental design and hold a high bar for data quality documentation and interpretation. You communicate clearly ask good questions and enjoy partnering across teams to turn complex data into shared understanding and practical decisions. You are adaptable resourceful motivated by impact more than rigid job boundaries and excited to help build the analytical foundation that will move complex cell therapy products toward the clinic.

• 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.