Principal Scientist, Cell Potency Analytics – NK Therapies

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 170,000 - 185,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) Retirement Plan

Paid Time Off (PTO)

Company holidays

Job summary

Artiva Biotherapeutics Inc. is seeking a senior leader to head the cell potency analytical development group for allogeneic NK cell therapies. You will define assay development strategy, direct validation, and mentor scientists to advance product characterization and release.

You will collaborate with R&D and Process Development to align product attributes with development goals and oversee assay transfers to QC labs, ensuring robust data for regulatory submissions.

Qualifications

• Ph.D. degree in a relevant scientific discipline with 10+ years of industry experience in analytical development or equivalent experience.
• Expertise in cell-based potency assay development; NK/CAR-T experience highly desirable.
• Experience with assay validation preferred.
• Experience with analytical techniques such as cell-based potency assays, flow cytometry, ELISA/MSD, and qPCR/ddPCR.

Responsibilities

• Lead and set the scientific strategy for the cell potency analytical development group and direct assay development activities.
• Serve as the SME for cell potency and represent the function on cross-functional teams.
• Design and execute assay qualification and validation studies to support product characterization and release.
• Review and draft SOPs/reports and communicate findings to the organization.
• Mentor scientists and analysts, and oversee transfers to QC labs where applicable.
• Prepare potency-related sections of regulatory submissions (IND/BLA) and respond to health authority queries.
• Present data to cross-functional teams and support process development and clinical release activities.

Skills

Cell potency assays

NK/CAR-T experience

Regulatory submissions

Analytical development

Leadership

Flow cytometry

qPCR/ddPCR

GXP regulated environment

Statistical software

Mentoring

Education

Ph.D. in a relevant science

Tools

JMP

Job description

Artiva Biotherapeutics Inc. is seeking a senior leader to head the cell potency analytical development group for allogeneic NK cell therapies. You will define assay development strategy, direct validation, and mentor scientists to advance product characterization and release.

You will collaborate with R&D and Process Development to align product attributes with development goals and oversee assay transfers to QC labs, ensuring robust data for regulatory submissions.