Scientist, Analytical Development

Job Description

Job Description

We are seeking a highly motivated and scientifically rigorous Scientist to join the Analytical Development team to support the development and validation of analytical methods for Kenai Therapeutic’s programs from early development through to commercial launch. This position is focused on the development, optimization and validation of flow cytometry assays to support critical activities associated with characterization and release of Kenai Therapeutic’s product pipelines. The Scientist will work closely within the CMC team to consistently deliver quality data by maintaining continuous operations of flow cytometry related activities. The candidate will have expertise in multi-color flow cytometry assay design and development, data analysis and presentation, robust experience with digital flow cytometry instrumentation operation and maintenance, and good documentation practices for project execution in a fast-paced biotech environment. This role is on-site in San Diego, CA and reports to the Director of Analytical Development.

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 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 CRO’s and vendors to ensure analytical readiness for clinical milestones. .

• Demonstrate Excellent written, verbal and interpersonal communication skills

Requirements

Required Qualifications

• Ph.D. in Immunology, Cell Biology, Neuroscience or related field with 2-5 years or M.S. with 6+ years of analytical development relevant industry 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, eg., CytoFLEX, MacsQuant, Attune, and/ 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 CDMO’s and CRO’s 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.

Benefits

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