We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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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 cytometry–based 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 therapies. In 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.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* 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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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