Senior Scientist, Stem Cell Product Attribute Sciences (Allogeneic Cell Therapy)

Key Responsibilities Method Translation & Standardization: transition exploratory research protocols into standardized Standard Operating Procedures (SOPs) for a rigorous CMC environment. Regulatory Data Generation: lead the generation and validation of critical data required for Module 3 of IND filings. Safety & Purity Testing: develop and execute ultra‑sensitive assays (e.g., ddPCR, multi‑color Flow Cytometry) to detect residual undifferentiated pluripotent stem cells and meet FDA safety requirements. Phenotypic Fingerprinting: establish lineage‑specific characterization protocols for batch‑to‑batch consistency and biological identity of differentiated products. Potency Assay Development: create MoA‑reflective assays that demonstrate in‑vitro biological function of differentiated cell products. Cross‑Functional Strategy: serve as the primary liaison between Research and Development teams to ensure Critical Quality Attributes (CQAs) are measurable, scalable, and clinically relevant. Qualifications Ph.D. in Stem Cell Biology, Regenerative Medicine, or related field with a thesis focused on complex cell characterization or differentiation (0–2 years industry experience). Expert‑level, hands‑on experience with ddPCR and multi‑color Flow Cytometry (10+ colors). Must be a go‑to resource for troubleshooting these instruments. Scientist‑as‑Architect mindset: passion for building assays from the ground up to be robust, reproducible, and precise. Foundational understanding of the drug development lifecycle with a strong desire to specialize in the CMC (Chemistry, Manufacturing, and Controls) space. Fast‑learner: ability to pivot from a research‑heavy mindset to a quality‑driven one while retaining scientific curiosity. Preferred Direct experience with induced pluripotent stem cell (iPSC) or embryonic stem cell (ESC)‑derived products. Previous experience writing sections for IND or BLA submissions. Familiarity with Design of Experiments (DoE) software for assay optimization. Relocation benefits available. Salary & Location South San Francisco, CA: $104,700 – $194,400, payable based on experience, qualifications, geographic location, and other factors permitted by law. May include discretionary annual bonus and eligibility for company benefits. Benefits Genentech offers a comprehensive benefits package. For details, refer to the benefits link provided in the application. Equal Opportunity Employment Statement Genentech is an equal opportunity employer. The company’s policy prohibits unlawful discrimination on the basis of Veteran status, disability status, or any other protected characteristic in accordance with all federal, state, and local laws. If you have a disability and need an accommodation during the online application process, please contact us by completing the Accommodations for Applicants form. #J-18808-Ljbffr F. Hoffmann-La Roche AG