Senior Scientist, Stem Cell Product Attribute Sciences (Allogeneic Cell Therapy)
Genentech · South San Francisco, California, United States
Full-time Posted 4 days ago
About this role
<h3>The Position</h3><p><span>A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come
Creating a world where we all have more time with the people we love. That’s what makes us Genentech!</span></p><p></p><p><span>The Mission: We are moving beyond the limitations of patient-specific therapies to build the future of "off-the-shelf" medicine. Our Allogeneic platform is designed to provide life-saving treatments at a global scale
To get there, we need to bridge the gap between exploratory research and clinical manufacturing. We are looking for an expert who can lead the translation of exploratory research assays into precise, robust, and IND-enabling methods. This is a critical role where you will not only characterize starting materials but develop assays to elucidate definitive proof of lineage commitment and product safety required for clinical success.</span></p><p></p><h1><b>The Opportunity</b></h1><p><span>This role offers the unique opportunity to work at the cutting edge of cell therapy
The work you do here tackles the "next frontier" of complexity in regenerative medicine. You will be the architect of the assays that ensure our most innovative products are safe, consistent, and ready for the patients who need them.</span></p><p>Key Responsibilities</p><ul><li><p>Method Translation & Standardization:<span> Transition exploratory research protocols into standardized Standard Operating Procedures (SOPs) designed for a rigorous CMC environment.</span></p></li><li><p>Regulatory Data Generation:<span> Lead the generation and validation of critical data required for Module 3 of Investigational New Drug (IND) filings.</span></p></li><li><p>Safety & Purity Testing:<span> Develop and execute ultra-sensitive assays (e.g., ddPCR, multi-color Flow Cytometry) for the detection of residual undifferentiated pluripotent stem cells to meet stringent FDA s
Apply for this role on Genentech’s official careers site.