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South San Francisco, California, United States
Onsite
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!
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.
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.
Key Responsibilities
Method Translation & Standardization: Transition exploratory research protocols into standardized Standard Operating Procedures (SOPs) designed for a rigorous CMC environment.
Regulatory Data Generation: Lead the generation and validation of critical data required for Module 3 of Investigational New Drug (IND) filings.
Safety & Purity Testing: 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 safety requirements.
Phenotypic Fingerprinting: Establish lineage-specific characterization protocols to ensure batch-to-batch consistency and biological identity of differentiated products.
Potency Assay Development: Create Mechanism of Action (MoA)-reflective assays to demonstrate in vitro biological function of differentiated cell products.
Cross-Functional Strategy: Act as the primary liaison between Research and Development teams to ensure "Critical Quality Attributes" (CQAs) are measurable, scalable, and clinically relevant.
Job Requirements:
Academic ExcellencePh.D. in Stem Cell Biology, Regenerative Medicine, or a related field (0-2 years experience in industry), with a thesis focused on complex cell characterization or differentiation.
Technical Deep-Dive: Expert-level hands-on experience with ddPCR and multi-color Flow Cytometry (10+ colors). You should be the person others go to for troubleshooting these instruments.
The "Scientist-as-Architect" Mindset: A passion for not just running assays, but building them from the ground up to be robust, reproducible, and precise.
CMC Curiosity & Literacy: You have a foundational understanding of the drug development lifecycle and a strong desire to specialize in the CMC (Chemistry, Manufacturing, and Controls) space. You are eager to learn how to translate "bench science" into the standardized, high-stakes environment of clinical manufacturing.
Agility: A "fast-learner" track record—you can pivot from a research-heavy mindset to a quality-driven one without losing your 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 are available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $104,700 - 194,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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