Scientist, Analytical Development

About the role

We are seeking a highly motivated and scientifically rigorous Scientist to join the Analytical Development team. This position focuses on the development, optimization, and validation of flow cytometry assays to support critical activities associated with characterization and release of Kenai Therapeutics' product pipelines from early development through to commercial launch. The Scientist will work closely within the CMC team to consistently deliver quality data by maintaining continuous operations of flow cytometry-related activities. This role is on-site in San Diego, CA.

Responsibilities

• Independently design, plan, and conduct multicolor flow cytometry-based laboratory experiments.
• Execute all aspects of flow cytometry daily activities, including instrument setup, sample preparation, staining, acquisition, and data analysis using different instrument software and/or external industry-standard software packages.
• Maintain and manage cell lines and banks for use in analytical assay development work.
• Implement scientifically sound gating strategies and establish standardized analysis templates.
• Design and perform assay robustness studies and troubleshoot signal artifacts, background populations, and spectral overlap issues.
• Generate, analyze, and present scientific data in cross-functional meetings.
• Apply statistical data analysis techniques using JMP, GraphPad Prism, and Excel to support experimental design and data interpretation.
• Prepare assay development/technical reports, protocols, standard operating procedures, and other relevant documents following industry-standard documentation practices.
• Conduct risk/gap assessments for method development and optimization at various phases of the program lifecycle.
• Ensure assays are fit-for-purpose and aligned with phase-appropriate regulatory expectations by exhibiting a strong understanding of regulatory principles as applicable to analytical development and validation activities.
• Keep current on relevant scientific literature, new technologies/capabilities, and support their implementation as appropriate.
• Maintain detailed records of executed lab work and reported results and data interpretation using electronic lab notebooks.
• Partner with Process Development, Quality, Research teams, and external CROs and vendors to ensure analytical readiness for clinical milestones.
• Demonstrate excellent written, verbal, and interpersonal communication skills.

Requirements

• Ph.D. in Immunology, Cell Biology, Neuroscience, or related field with 2-5 years of analytical development-relevant industry experience, or M.S. with 6+ years of relevant experience.
• Deep expertise in multiparameter flow cytometry assay development, analysis, compensation, and gating strategies.
• Strong understanding of ICH guidelines for analytical method development and validation and phase-appropriate method lifecycle management.
• Scientifically strong technical writing skills.
• Strong analytical skills and experience in operating and maintaining advanced flow cytometry instruments (e.g., CytoFLEX, MacsQuant, Attune, or equivalent platforms).
• Strong understanding of cell therapy product characterization (e.g., iPSC/ESC-derived).
• Proficiency with FlowJo, CytExpert, and/or equivalent data analysis platforms.
• Excellent organization skills and time management skills to work independently and balance multiple tasks and projects.
• Hands-on experience with cell handling of suspension/adherent cultures in BSC operations.
• Ability to clearly convey scientific findings and development rationale.
• Ability to work in a small, fast-paced, cross-collaborative environment with strong listening, communication, and collaboration skills.

Preferred Qualifications

• Experience supporting clinical programs from early phase to commercialization.
• Experience in assay transfers between CDMOs, CROs, and internal teams.
• Familiarity with advanced statistical analysis approaches for assay development and validation.
• Prior experience in a startup or early-phase biotech environment.
• Strong organizational skills that facilitate planning, multitasking, and balancing tight timelines.

Pay

The salary range for this position is $110,000 USD to $135,000 USD annually. This range is an estimate, and the actual salary may vary based on experience and/or the Company's compensation practices.