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Redwood City, California, United States
Onsite
Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to broadly improve tissue function by targeting mechanisms of aging with the ultimate aim of adding 10 years to healthy human lifespan.
We’re building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility.
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 programs. In 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.
We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.