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

Genentech • Daly City, CA

4d • $104,700 - $194,400 • Onsite

About The Position

Genentech is seeking a Senior Scientist to join their Allogeneic platform team, focusing on building the future of 'off-the-shelf' medicine. This role is crucial for bridging the gap between exploratory research and clinical manufacturing by leading the translation of research assays into precise, robust, and IND-enabling methods. The scientist will characterize starting materials and develop assays to prove lineage commitment and product safety for clinical success, working at the forefront of cell therapy and regenerative medicine.

Requirements

• Ph.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.
• Expert-level hands-on experience with ddPCR and multi-color Flow Cytometry (10+ colors).
• A passion for building robust, reproducible, and precise assays from the ground up.
• Foundational understanding of the drug development lifecycle and a strong desire to specialize in the CMC (Chemistry, Manufacturing, and Controls) space.
• Ability to translate 'bench science' into the standardized, high-stakes environment of clinical manufacturing.
• A 'fast-learner' track record—ability to pivot from a research-heavy mindset to a quality-driven one without losing scientific curiosity.

Nice To Haves

• 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.

Responsibilities

• Transition exploratory research protocols into standardized Standard Operating Procedures (SOPs) designed for a rigorous CMC environment.
• Lead the generation and validation of critical data required for Module 3 of Investigational New Drug (IND) filings.
• 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.
• Establish lineage-specific characterization protocols to ensure batch-to-batch consistency and biological identity of differentiated products.
• Create Mechanism of Action (MoA)-reflective assays to demonstrate in vitro biological function of differentiated cell products.
• Act as the primary liaison between Research and Development teams to ensure 'Critical Quality Attributes' (CQAs) are measurable, scalable, and clinically relevant.

Benefits

• Relocation benefits are available.
• Discretionary annual bonus may be available based on individual and Company performance.
• Benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree