Associate Research Scientist, Process Impurities Development

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Job Description

We are seeking a highly motivated Associate Research Scientist to join our Process Impurities Development team within the Method Development and Automation function. This role focuses on the development, optimization, and validation of analytical methods supporting residual impurity testing, host cell protein (HCP) analysis, compendial testing, and raw material characterization to support gene and cell therapy manufacturing.

The successful candidate will bring strong experience with ELISA, ELLA, and molecular biology techniques, along with a working knowledge of ICH, USP, and EU regulatory guidelines for analytical method development. You will play a critical role in ensuring product safety and consistency by supporting process development and tech transfer activities across the organization.

Title : Associate Research Scientist I, Process Impurities Development

Team : Analytical Development, Process Impurities, Method Development

Reports to : Principal Scientist, Analytical Ops

Key Responsibilities

• Develop and optimize analytical methods for detection and quantification of residual impurities, including Host Cell Proteins and nucleic acids

• Perform and validate ELISA- and ELLA-based assays for impurity profiling

• Execute molecular biology methods (e.g., qPCR, ddPCR) to support residual DNA or RNA detection

• Conduct compendial testing per USP, EP, and other regulatory guidelines for raw materials and in-process components

• Design and execute method validation studies in accordance with ICH, USP, and EU requirements

• Troubleshoot assay performance issues and implement continuous improvements

• Collaborate cross-functionally with Process Development, Quality, and Manufacturing teams to integrate analytical methods into development workflows

• Document experimental protocols, validation reports, and supporting SOPs in accordance with GDP and regulatory standards

• Maintain compliance with GMP and internal quality systems

Basic Qualifications

• BA / BS and 4+ years of relevant experience

• MA / MS and 2+ years of relevant experience

• Degree in Biochemistry, Molecular Biology, Analytical Chemistry, or a related discipline

Preferred Qualifications

• Demonstrated expertise in ELISA, ELLA (e.g., ProteinSimple Ella platform), and quantitative molecular assays

• Familiarity with impurity testing for biologics or gene therapies (e.g., HCP assays, residual DNA/RNA, enzyme activity)

• Proven experience developing and validating analytical methods in alignment with ICH Q2(R2), USP, and EU guidelines

• Working knowledge of compendial methods and regulatory standards (USP , , , etc.)

• Proficiency in data analysis using software such as SoftMax Pro, GraphPad Prism, and JMP

• Excellent technical writing skills for protocols, reports, and submissions

• Strong collaborative mindset and communication skills

• Comfortable working in a dynamic biotech environment with evolving priorities and timelines

The salary range for this position is: $99,705.00 - $129,030.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* 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 .

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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.

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