Principal Scientist
Gilead Sciences, Inc.
Job Description
Job Description
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Kite is seeking a highly motivated Principal Scientist with a strong background in analytical method development to lead the Compendial and Impurities Team within Analytical Method Development. This role focuses on the development, validation, and life cycle management of compendial analytical methods, with a particular emphasis on process related impurities, host cell protein evaluations, method transfer, oversight of external partners (CMO/CTL), and PPQ readiness. The successful candidate will provide technical leadership, mentor team members, and drive strategic initiatives to ensure robust, phase-appropriate assays for gene-modified cell therapies, aligning with regulatory expectations and industry best practices.
Key Responsibilities
Lead and manage the Compendial and Impurities Team, providing mentorship, technical guidance, and strategic direction to ensure high-quality analytical method development and execution.
Develop and implement host cell protein assays using ELISA, Ella, or mass spectrometry, ensuring comprehensive coverage assessments and alignment with regulatory expectations.
Develop, validate, and oversee compendial and safety method development for mycoplasma, endotoxin, sterility, replication competent lentivector, and other critical quality attributes to ensure regulatory compliance and product safety.
Lead analytical method transfers to external partners, including contract manufacturing organizations and contract testing laboratories. Ensure successful implementation, compliance with GxP guidelines, and alignment with quality and regulatory standards.
Support process performance qualification activities by ensuring validated analytical methods are suitable for lot release and stability testing. Collaborate with Process Development and Quality teams to maintain assay consistency across manufacturing sites.
Develop, optimize, validate, and manage the life cycle of compendial methods (e.g., USP, EP, JP) for the characterization and quality assessment of gene-modified cell therapies. Ensure compliance with evolving regulatory expectations for advanced therapy medicinal products.
Oversee the continuous improvement and adaptation of analytical methods to ensure long-term suitability and robustness. Implement trend analysis and method performance monitoring to proactively address regulatory updates, industry advancements, and shifting product needs.
Apply statistical analysis and data interpretation techniques to assess assay performance, method robustness, and long-term stability. Utilize risk-based approaches to troubleshoot technical challenges and optimize analytical procedures.
Author and review technical documents, including validation protocols, regulatory submissions, and SOPs, ensuring clear alignment with global regulatory expectations and compendial method requirements.
Work closely with Quality Control, Process Development, and Manufacturing teams to ensure analytical methods remain aligned with product and process requirements throughout their life cycle.
Basic Qualifications
PhD and 5+ years of relevant industry experience; OR
Masters degree and 8+ years of relevant industry experience; OR
Bachelors degree and 10+ years of relevant industry experience.
Degree in Biological Sciences or related field.
Industry experience in biotech, gene therapy, or pharmaceutical environments.
Preferred Qualifications
Proven experience in developing and validating HCP assays, including ELISA-based methods and orthogonal approaches for coverage assessments.
Strong expertise in analytical method development, qualification, validation, and lifecycle management for biologics or cell/gene therapies.
Familiarity with GxP guidelines and regulatory expectations for compendial methods, PPQ, and external laboratory oversight.
Experience in team leadership and management, including mentoring scientists, driving strategic initiatives, and overseeing analytical operations.
Method Transfer & Partner Oversight: Experience managing method transfers to external CMOs/CTLs, ensuring compliance and successful implementation.
Proficiency in data analysis software (e.g., MS Excel, JMP, GraphPad Prism) and statistical evaluation for assay development and validation.
Strong scientific writing skills with experience preparing validation reports, regulatory submissions, and SOPs.
Excellent ability to diagnose assay performance challenges and implement effective solutions.
Comfortable working in a dynamic, fast-paced environment with evolving priorities and cross-functional integration.
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Job Description
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Kite is seeking a highly motivated Principal Scientist with a strong background in analytical method development to lead the Compendial and Impurities Team within Analytical Method Development. This role focuses on the development, validation, and life cycle management of compendial analytical methods, with a particular emphasis on process related impurities, host cell protein evaluations, method transfer, oversight of external partners (CMO/CTL), and PPQ readiness. The successful candidate will provide technical leadership, mentor team members, and drive strategic initiatives to ensure robust, phase-appropriate assays for gene-modified cell therapies, aligning with regulatory expectations and industry best practices.
Key Responsibilities
Lead and manage the Compendial and Impurities Team, providing mentorship, technical guidance, and strategic direction to ensure high-quality analytical method development and execution.
Develop and implement host cell protein assays using ELISA, Ella, or mass spectrometry, ensuring comprehensive coverage assessments and alignment with regulatory expectations.
Develop, validate, and oversee compendial and safety method development for mycoplasma, endotoxin, sterility, replication competent lentivector, and other critical quality attributes to ensure regulatory compliance and product safety.
Lead analytical method transfers to external partners, including contract manufacturing organizations and contract testing laboratories. Ensure successful implementation, compliance with GxP guidelines, and alignment with quality and regulatory standards.
Support process performance qualification activities by ensuring validated analytical methods are suitable for lot release and stability testing. Collaborate with Process Development and Quality teams to maintain assay consistency across manufacturing sites.
Develop, optimize, validate, and manage the life cycle of compendial methods (e.g., USP, EP, JP) for the characterization and quality assessment of gene-modified cell therapies. Ensure compliance with evolving regulatory expectations for advanced therapy medicinal products.
Oversee the continuous improvement and adaptation of analytical methods to ensure long-term suitability and robustness. Implement trend analysis and method performance monitoring to proactively address regulatory updates, industry advancements, and shifting product needs.
Apply statistical analysis and data interpretation techniques to assess assay performance, method robustness, and long-term stability. Utilize risk-based approaches to troubleshoot technical challenges and optimize analytical procedures.
Author and review technical documents, including validation protocols, regulatory submissions, and SOPs, ensuring clear alignment with global regulatory expectations and compendial method requirements.
Work closely with Quality Control, Process Development, and Manufacturing teams to ensure analytical methods remain aligned with product and process requirements throughout their life cycle.
Basic Qualifications
PhD and 5+ years of relevant industry experience; OR
Masters degree and 8+ years of relevant industry experience; OR
Bachelors degree and 10+ years of relevant industry experience.
Degree in Biological Sciences or related field.
Industry experience in biotech, gene therapy, or pharmaceutical environments.
Preferred Qualifications
Proven experience in developing and validating HCP assays, including ELISA-based methods and orthogonal approaches for coverage assessments.
Strong expertise in analytical method development, qualification, validation, and lifecycle management for biologics or cell/gene therapies.
Familiarity with GxP guidelines and regulatory expectations for compendial methods, PPQ, and external laboratory oversight.
Experience in team leadership and management, including mentoring scientists, driving strategic initiatives, and overseeing analytical operations.
Method Transfer & Partner Oversight: Experience managing method transfers to external CMOs/CTLs, ensuring compliance and successful implementation.
Proficiency in data analysis software (e.g., MS Excel, JMP, GraphPad Prism) and statistical evaluation for assay development and validation.
Strong scientific writing skills with experience preparing validation reports, regulatory submissions, and SOPs.
Excellent ability to diagnose assay performance challenges and implement effective solutions.
Comfortable working in a dynamic, fast-paced environment with evolving priorities and cross-functional integration.
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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 . Sign up to follow @KitePharma on Twitter at .
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For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
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Job Requisition ID R0045750
Full Time/Part Time Full-Time
Job Level Associate Director
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