Scientist, Analytical Development

Role overview

Kenai Therapeutics is looking for a driven and detail-oriented Scientist to join its Analytical Development function in San Diego, California. The role supports the creation, refinement, and validation of analytical methods across programs from the earliest development stages through commercial readiness. A major focus of the position is multicolor flow cytometry assay development, optimization, and validation to help characterize products and support release activities across the pipeline.

This scientist will work closely with the CMC organization to help ensure reliable, high-quality data and continuous support for flow cytometry-related work. The position requires strong expertise in assay design, data analysis, instrument operation and upkeep, and careful documentation in a fast-moving biotech setting. The role is on-site and reports to the Director of Analytical Development.

Key responsibilities

• Independently plan, design, and run multicolor flow cytometry experiments.
• Carry out daily flow cytometry tasks such as instrument setup, sample handling, staining, acquisition, and data analysis using vendor software and other standard tools.
• Maintain cell lines and cell banks used in analytical assay development.
• Create scientifically justified gating approaches and build standardized analysis templates.
• Design robustness studies and investigate issues such as signal artifacts, background populations, and spectral overlap.
• Prepare, interpret, and present scientific results in cross-functional meetings.
• Use statistical tools such as JMP, GraphPad Prism, and Excel to support experimental planning and data interpretation.
• Draft assay development reports, technical documents, protocols, SOPs, and related records using industry-standard documentation practices.
• Perform risk and gap assessments to guide method development and optimization across different program stages.
• Confirm that assays are suitable for purpose and aligned with phase-appropriate regulatory expectations.
• Stay up to date on scientific advances, new technologies, and practical improvements relevant to the role.
• Keep thorough lab records and data interpretation notes in electronic lab notebooks.
• Collaborate with Process Development, Quality, Research, CROs, and vendors to support readiness for clinical milestones.
• Communicate scientific findings clearly in written, verbal, and interpersonal formats.

Required qualifications

• Ph.D. in Immunology, Cell Biology, Neuroscience, or a related discipline with 2-5 years of relevant analytical development experience, or an M.S. with 6+ years of relevant industry experience.
• Strong hands-on expertise in multiparameter flow cytometry assay development, analysis, compensation, and gating strategies.
• Solid understanding of ICH guidance for analytical method development, validation, and lifecycle management.
• Strong technical writing ability with a scientific focus.
• Experience operating and maintaining advanced flow cytometry instruments such as CytoFLEX, MacsQuant, Attune, or similar systems.
• Working knowledge of cell therapy product characterization, including iPSC/ESC-derived products.
• Proficiency with data analysis tools such as FlowJo and CytExpert, or comparable platforms.
• Excellent organization and time-management skills, with the ability to work independently and manage multiple priorities.
• Practical experience handling suspension and adherent cell cultures in biosafety cabinet operations.
• Ability to explain scientific results and development decisions clearly.
• Comfort working in a small, fast-moving, highly collaborative team with strong listening and teamwork skills.

Preferred experience

• Background supporting clinical programs from early development through commercialization.
• Experience transferring assays between CDMOs, CROs, and internal teams.
• Exposure to advanced statistical approaches for assay development and validation.
• Experience in a startup or early-stage biotech environment.
• Strong planning and multitasking skills for working against tight deadlines.

Compensation

The annual salary range for this role is USD 110,000 to USD 135,000. The company notes that the actual offer may differ depending on experience and compensation practices.

Work arrangement

This is a full-time, on-site position based in San Diego, CA.