Associate/Scientist / Senior Scientist – Exosome Analytics & Characterization

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<p><strong>Associate/Scientist / Senior Scientist – Exosome Analytics & Characterization</strong></p><p><strong>Location:</strong> Watertown/Cambridge, MA (on‑site laboratory role)</p><p><br></p><p> </p><p><strong>About the Role</strong></p><p>We are seeking a highly motivated <strong>analytical scientist</strong> to lead and execute <strong>exosome (extracellular vesicle, EV) analytical assays</strong> supporting the development of <strong>iPSC‑derived MSC exosome therapeutics</strong> for veterinary indications. This role is <strong>hands‑on and lab‑based</strong>, with responsibility for developing, optimizing, qualifying, and running assays that define <strong>identity, purity, potency, and consistency</strong> of exosome products across research, preclinical, and GMP‑adjacent workflows.</p><p><br></p><p>This is an ideal role for someone who enjoys <strong>owning assays end‑to‑end</strong>, working closely with process development, and building analytically defensible datasets that will ultimately support regulatory submissions.</p><p><br></p><p><br></p><p><strong>Key Responsibilities</strong></p><p><strong>Exosome Analytical Assays (Core Focus)</strong></p><ul><li>Develop, optimize, and routinely execute <strong>exosome characterization assays</strong>, including but not limited to:</li><li>Particle concentration and size (e.g., NTA or alternative orthogonal methods)</li><li>Identity and marker expression (e.g., WB, ELISA, bead‑based assays)</li><li>Purity and impurity assessment (protein, lipid, residual process components)</li><li>Establish <strong>fit‑for‑purpose potency assays</strong> (cell‑based and/or biochemical) aligned with mechanism of action.</li><li>Perform analytical comparability studies to support:</li><li>Process optimization (e.g., media, culture density, DSP changes)</li><li>batch‑to‑batch consistency</li></ul><p><br></p><p><strong>Assay Lifecycle & Rigor </strong></p><ul><li>Design and execute <strong>assay qualification activities</strong> (accuracy, precision, linearity, range, robustness).</li><li>Support eventual <strong>assay validation</strong> for assays intended for regulatory use.</li><li>Define scientifically justified <strong>acceptance criteria</strong> and trending approaches.</li><li>Maintain assay SOPs, protocols, and controlled documentation.</li></ul><p><br></p><p><strong>Data & Documentation</strong></p><ul><li>Analyze and interpret complex analytical datasets with strong statistical awareness. <strong>(<em>only for senior scientist-level)</em></strong></li><li>Prepare clear summaries for internal decision‑making and regulatory‑facing documentation. <strong>(<em>only for senior scientist-level)</em></strong></li><li>Contribute to CMC sections related to analytical methods, assay performance, and product characterization.</li></ul><p><br></p><p><br></p><p><strong>Required Qualifications</strong></p><ul><li>MS or PhD in Analytical Chemistry, Biochemistry, Cell Biology, Bioengineering, or related field.</li><li>Hands‑on experience developing and running <strong>biological or cell‑based assays</strong>.</li><li>Strong experimental design, data analysis, and troubleshooting skills.</li><li>Comfortable working in a <strong>fast‑moving, early‑stage biotech lab environment</strong>.</li><li>Lawful resident status (green card) or proof of US citizenship required</li></ul><p><br></p><p>Experience with at least several of the following:</p><ul><li>Nanoparticle tracking analysis (NTA) or similar particle sizing methods</li><li>Western blot, ELISA, or immunoassays</li><li>Cell‑based functional or potency assays</li><li>Protein and/or lipid quantification methods</li></ul><p><br></p><p><br></p><p><strong>Preferred Qualifications</strong></p><ul><li>Direct experience with <strong>exosomes or extracellular vesicles</strong>.</li><li>Experience supporting <strong>GMP, preclinical, or regulated programs</strong> (CVM, CBER, or similar).</li><li>Familiarity with assay qualification vs validation concepts.</li><li>Experience working with iPSC‑derived cells, MSCs, or conditioned media products.</li><li>Experience interfacing with external testing labs or CDMOs.</li></ul><p><br></p><p><br></p><p><strong>What We’re Looking For</strong></p><ul><li>A <strong>hands‑on experimentalist</strong>, not a purely managerial profile.</li><li>Someone who enjoys building assays where standards are still evolving.</li><li>Strong scientific judgment and comfort making data‑driven recommendations.</li><li>Clear communicator who can translate analytical results to non‑analytical teammates.</li></ul><p><br></p><p><br></p><p><strong>Why Join Us</strong></p><ul><li>Opportunity to shape <strong>best‑in‑class analytics</strong> for a rapidly emerging therapeutic modality.</li><li>High scientific ownership and visibility across development decisions.</li><li>Work at the interface of <strong>analytics, process development, and translational biology</strong>.</li><li>Mission‑driven program focused on bringing advanced biologics to veterinary medicine.</li></ul><p><br></p><p><br></p>

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