Sr Associate Scientist, Analytical Ops

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Job Description

We are seeking a Senior Associate Scientist to join Analytical Development where you will develop optimize qualify and transfer potency assays supporting characterization and lot release testing for cell and gene therapy programs. You will bring hands-on expertise in flow cytometry and immunoassay platforms (ELISA and ProteinSimple Ella) to build robust phase-appropriate methods with well-defined controls standards and acceptance criteria. You will collaborate closely with Process Development QC Manufacturing and Quality to ensure methods are transferable compliant and inspection-ready with strong documentation practices and data integrity expectations.

The successful candidate will bring strong hands-on experience with flow cytometry and immunoassay platforms (ELISA and ProteinSimple Ella) and a solid understanding of potency strategy assay controls/standards and data quality. While this role sits in Analytical Development it requires a strong QC mindset: designing assays that are robust transferable and inspection-ready with clear system suitability acceptance criteria and compliant documentation. You will partner closely with Process Development QC and Quality to ensure methods are phase-appropriate and can be executed reproducibly for characterization and lot release.

Key Responsibilities

• Develop optimize and qualify potency assays to support product characterization process development and lot release for cell and gene therapy programs

• Design and execute flow cytometrybased assays (e.g. phenotyping receptor/ligand binding functional readouts) including panel design instrument setup and gating strategy development

• Develop and run immunoassays (ELISA and Ella) to measure potency-relevant analytes (e.g. cytokines activation markers soluble ligands) and support assay lifecycle management

• Perform cell-based functional potency assays (as applicable) including assay setup reagent qualification acceptance criteria and troubleshooting of performance issues

• Plan and execute assay qualification/validation studies (e.g. accuracy precision linearity range specificity robustness) aligned with ICH/USP guidance and phase-appropriate requirements

• Troubleshoot assay performance (flow ELISA Ella and cell-based assays) and drive continuous improvements to robustness throughput and data integrity

• Collaborate cross-functionally with Process Development QC Quality and Manufacturing to align on potency strategy define assay requirements and support method transfer activities

• Establish QC-ready assay elements (reference standards/controls system suitability plate/run layouts acceptance criteria) and ensure methods are fit-for-purpose rugged and transferable

• Author and review protocols technical reports and SOPs in accordance with GDP/GMP expectations; ensure traceable documentation and alignment with internal quality systems

• Perform data trending and monitoring (e.g. control charts OOT signals reagent lots) and partner with QC/Quality on assay lifecycle activities such as change control reagent qualification and method updates

• Support QC investigations (deviations OOS/OOT) by providing technical assessment experimental follow-up and clear documentation; contribute to CAPA and risk assessments as needed

• Maintain compliance with GMP and internal quality systems; support deviations investigations and inspection readiness as needed

Qualifications

• BS in Biochemistry Molecular Biology Analytical Chemistry or a related discipline with 8 years of relevant industry experience or MS with 6 years

• Demonstrated expertise in flow cytometry and immunoassays including ELISA and ProteinSimple Ella (or similar automated immunoassay platforms)

• Experience developing qualifying and troubleshooting potency assays (including cell-based functional assays) for biologics cell therapy and/or gene therapy programs

• Proven experience authoring and executing assay qualification/validation plans and reports in alignment with ICH Q2 principles and internal quality standards

• Familiarity with QbD concepts for analytical methods (e.g. defining assay intent critical method parameters robustness/ruggedness control strategy) and relevant ICH and health authority expectations for potency methods across development stages

• Prior experience in a QC environment and/or strong QC-facing Analytical Development experience (e.g. method transfer release testing support controlled documentation deviations/OOS investigations)

• Working knowledge of potency assay considerations (e.g. reference standards system suitability controls assay drift) and phase-appropriate CMC expectations

• Understanding of data integrity expectations (ALCOA) and experience working within GxP quality systems (e.g. controlled documents training change control deviation management)

• Proficiency in data analysis and visualization using tools such as FlowJo (or equivalent) and JMP; able to perform trending and summarize assay performance

• Excellent technical writing skills for protocols reports and submissions

• Strong collaborative mindset and communication skills

• Comfortable operating in a QC-style environment (right-first-time execution schedule-driven deliverables rigorous documentation and adherence to approved procedures)

Why Join Us Join a forward-thinking team focused on enabling the development of next-generation CAR T and gene this role you will have a direct impact on product quality by shaping and executing potency strategies and assays that support characterization and lot release. We offer a collaborative and fast-paced environment where you can grow technically and professionally while helping advance transformative treatments for patients in need.

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Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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