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United States - California - Santa Monica, United States of America
Onsite
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The Senior Scientist – Biophysical Attribute Sciences (Analytical Operations, Process Development) position is a site-based role at our Santa Monica, CA location.
Position Overview:
The Biophysical Attribute Sciences team, part of Analytical Development in Process Development, is seeking a Sr. Scientist with a strong background in biophysical characterization and analytical method development. In this role, you will work with cross-functional teams to design and execute advanced biophysical analysis of gene and cell therapy products.
By applying physical-analytical techniques and data analytics, you will help connect product and process attributes to critical quality profiles and support process optimization, comparability studies, and control strategy development across all stages of product lifecycle. The successful candidate will contribute to method innovation and ensure that our biophysical assays meet the needs of early and late-stage development and regulatory (CMC) requirements, enabling robust analytical control strategies and filings.
This position provides an opportunity to play a key role in driving an advanced biophysical characterization toolkit to inform product quality and process improvements.
Key Responsibilities include but are not limited to:
Analytical Method Development & Characterization: Design and execute phase-appropriate biophysical characterization methods (e.g. light scattering, particle tracking, subvisible particle analysis) to evaluate and biophysical attributes of cell therapy products. Optimize and innovate assay conditions, ensuring high-resolution, reproducible measurement of critical quality attributes (CQAs).
Process Development Support & Control Strategy: Serve as the subject matter expert supporting vector and cell process development teams, providing data-driven insights to correlate process parameters with product attribute profiles. Contribute to analytical control strategy by identifying critical quality attributes and establishing comparability protocols for process changes and technology transfers.
Early and late-Stage Development & CMC Support: Support method qualification/validation and transfer of biophysical assays to Quality Control as needed, ensuring methods are fit for purpose for early and late-stage development, process characterization, and regulatory submissions (IND/BLA). Collaborate with Regulatory and Quality teams to provide scientific data, reports, and responses for CMC sections of regulatory filings.
Data Analysis & Reporting: Systematically record experimental data (e.g. in electronic lab notebooks) and perform thorough analysis and interpretation of results, applying appropriate statistical and data visualization tools. Identify trends or anomalies in biophysical data that may indicate process improvements or product quality issues. Document findings in technical reports and present results in cross-functional meetings to inform decision-making.
Laboratory Operations & Compliance: Operate, maintain, and troubleshoot advanced biophysical instrumentation to ensure high-quality data generation. Adhere to laboratory safety practices and quality compliance guidelines. Maintain a safe, orderly work environment aligned with 5S and EH&S standards, ensuring readiness for audits and inspections.
Collaboration & Communication: Work closely with scientists across Analytical Development and other departments to integrate biophysical characterization into broader development efforts. Contribute scientific expertise in cross-functional project teams, providing biophysical assay results and interpretations to support product investigations, process optimizations, and control strategy decisions.
Senior Scientists are expected to demonstrate greater independence and leadership. This includes leading technical projects or components of programs to successful completion, coordinating team efforts to meet project milestones, and introducing innovative analytical approaches. Senior Scientists are often recognized for specialized expertise and serve as technical resources to colleagues across the department, contributing new ideas that can influence project or departmental strategy. They also mentor junior team members and help enhance team capabilities.
Required Qualifications:
Education & Experience: Ph.D. in Analytical Chemistry, Biochemistry, Biophysics, Chemical Engineering, or a related discipline with 2+ years of experience required OR
MS in Analytical Chemistry, Biochemistry, Biophysics, Chemical Engineering, or a related discipline with 6+ years of experience required OR
BS in Analytical Chemistry, Biochemistry, Biophysics, Chemical Engineering, or a related discipline with 8+ years of experience required
Technical Expertise: Demonstrated hands-on experience with biophysical and analytical techniques relevant to biologics or viral vectors, such as particle sizing, light scattering, spectroscopic or imaging methods, or related instrumentation. Proven ability to develop, optimize, and execute complex analytical assays with precision and reliability.
Analytical & Scientific Skills: Strong data analysis and problem-solving abilities, including familiarity with data processing software (e.g. statistical tools, visualization).
Communication & Collaboration: Excellent written and verbal communication skills, with ability to compile comprehensive technical reports and present scientific data clearly to diverse audiences. Team-oriented mindset and experience working in cross-functional settings to drive projects forward.
Organizational & Documentation Skills: Meticulous record-keeping and ability to follow good documentation practices; familiarity with electronic lab notebooks and standard operating procedures (SOPs). Time-management skills to handle multiple projects effectively in a fast-paced environment.
Leadership: For Senior Scientist, evidence of successfully leading projects or technical initiatives with minimal supervision, and providing guidance or mentorship within a team setting.
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Preferred Qualifications:
Biologics/Vector Experience: Prior experience in analytical development for gene and cell therapies, or other complex biologics is highly desirable. Familiarity with vector manufacturing processes or cell therapy products is a plus.
Regulatory & Quality Knowledge: Understanding of analytical method validation requirements and regulatory expectations for late-stage/CMC development. Knowledge of ICH guidelines (e.g. ICH Q2) and Quality by Design (QbD) or Design of Experiments (DOE) principles for method development is a plus.
Problem-Solving and Innovation: Demonstrated ability to troubleshoot complex technical issues in analytical assays, and to introduce new technologies or innovative approaches for improved biophysical characterization.
Cross-Functional Insight: Experience contributing to process development initiatives, comparability protocols, or analytical control strategies for biologics. Proven ability to collaborate across R&D teams (e.g. Process Development, Quality, Regulatory) to ensure alignment of analytical activities with program goals is a plus.
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.
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