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Principal Scientist, Analytical Development

Artiva Biotherapeutics - San Diego, CA, United States - In-office

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Salary: USD 170,000 - 185,000 / annual

Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The company's lead product, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy designed for use in community settings. As Principal Scientist, Analytical Development, you will lead the cell potency analytical development team and set the strategic direction for developing and optimizing cell-based assays that support characterization and release of allogeneic NK cell therapies. You will serve as the scientific subject matter expert for cell potency, defining assay development strategy and directing evaluation of new potency assay methods and product characterization approaches. Key responsibilities include: leading and mentoring a team of scientists and analysts; providing scientific oversight of benchtop assay development; designing and executing assay qualification and validation studies; researching and comparing novel analytical platforms; developing assays for process development, clinical product release, stability, and characterization; drafting technical reports, SOPs, and test protocols; authoring and reviewing potency-related sections of regulatory submissions (IND/BLA); managing assay transfer to QC and external partners; and presenting findings to cross-functional teams. You will collaborate closely with R&D and Process Development teams to identify product attributes that advance optimal development and assess function. This role reports directly to the Director, Analytical Development. Required qualifications: Ph.D. in a relevant scientific discipline (Immunology, Microbiology, Cell/Molecular Biology, or Biochemistry) with 10+ years of industry experience in analytical development. Expertise in cell-based potency assay development is essential; NK cell and CAR-T cell experience is highly desirable. In-depth experience with analytical techniques including flow cytometry, ELISA/MSD, and qPCR/ddPCR is required. Strong interpersonal and written communication skills, ability to manage personnel and multiple projects, and demonstrated scientific leadership are essential. Experience authoring analytical/CMC sections of regulatory submissions is preferred. Experience in pharma/biotech regulated (GXP) environments, cell therapy, immunology, or oncology is strongly preferred.

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