Scientist, Analytical Ops (Process Impurities Development)

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Job Description

Scientist Process Impurities Development;Analytical Development Process Impurities Method Development Reports to: Associate Director Analytical Ops

Job Overview:

We are seeking a highly motivated Research Scientist to join our Process Impurities Development team within the Method Development and Automation function. This role primarily focuses on the development optimization and deployment of analytical methods supporting impurity compendial and safety testing and raw material characterization to support gene and cell therapy development and commercialization.

The successful candidate will bring strong experience in this area along with a working knowledge of ICH USP and EU regulatory guidelines. You will play a critical role in ensuring product safety and consistency by supporting process development and tech transfer activities across the organization.

Key Responsibilities:

• Serve as SME for compendial methods (USP Ph. Eur.) including appearance pH osmolality particulates and safety-related assays (e.g. sterility/CCIT mycoplasma endotoxin) and process impurity immunoassays (e.g. ELISA Ella Luminex).

• Own method development optimization robustness and troubleshooting as well as gap assessments and equivalency justifications.

• Provide technical input to QC readiness method deployments and external partner strategy.

• Author revise and approve compendial methods protocols and verification/compliance summary reports in alignment with internal standards and pharmacopeial expectations.

• Support method verification validation and lifecycle maintenance activities in accordance with ICH Q2 and compendial requirements.

• Support deviations investigations and CAPAs related to compendial and safety assays as a technical SME.

• Act as a technical liaison between Analytical Ops Quality Manufacturing Regulatory and external partners.

• Ensure patient and product safety through rigorous execution and oversight of safety analytical testing.

• Identify assess and mitigate analytical risks related to compendial methods raw materials and in-process controls.

• Communicate risks timelines and compliance considerations clearly to stakeholders and leadership.

• Contribute to standardization and continuous improvement of compendial practices across programs.

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

• Maintain compliance with GMP and internal quality systems.

Basic Qualifications:

• PhD (0 years) in Biochemistry Molecular Biology Analytical Chemistry or other related discipline;

or

• MS with 4 years;

or

• BS with 6 years of relevant industry experience in analytical development QC or regulated testing environments.

Preferred Qualifications:

• 2 Years with PhD in Biochemistry Molecular Biology Analytical Chemistry or other related discipline

• Operates independently with limited oversight and exercises sound scientific judgment.

• Recognized within the group as a go-to resource for compendial and safety testing with the ability to independently represent analytical risk compliance impact and recommended path forward.

• Proactively identifies gaps and risks supports equivalency assessments and compliance justifications and translates ambiguity into clear study plans decisions and stakeholder updates.

• Mentors junior staff provides technical guidance to peers and supports cross-training and knowledge transfer within Analytical Ops and QC-facing activities.

• Proven experience with impurity immunoassays and/or compendial and safety methods including development/optimization troubleshooting and readiness for QC or transfer into routine testing in alignment with ICH Q2(R2) USP and Ph. Eur. guidelines.

• Critical reagent strategy experience including qualification lot-to-lot bridging and supply continuity risk mitigation.

• Experience supporting GMP/QMS investigations and driving scientifically justified CAPAs related to compendial safety and impurity assays.

• Proficiency in data analysis using software such as 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.

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 ensuring the safety and quality of our cutting-edge therapies by shaping and executing analytical strategies for process impurities. 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:

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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