United States - California - Santa Monica, United States of America
Onsite
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Senior 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 6+ years of relevant industry experience in analytical development, QC, or regulated testing environments OR
BS with 8+ years of relevant industry experience in analytical development, QC, or regulated testing environments.
Preferred Qualifications:
4+ 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 therapies. In 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:
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.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.