Senior Scientist, Stem Cell Product Attribute Sciences (Allogeneic Cell Therapy)
About The Position
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.
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 not just running assays, but building them from the ground up to be robust, reproducible, and precise.
- A foundational understanding of the drug development lifecycle and a strong desire to specialize in the CMC (Chemistry, Manufacturing, and Controls) space.
- A "fast-learner" track record—you can pivot from a research-heavy mindset to a quality-driven one without losing your 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 for this job posting.
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
