Senior Scientist – Biophysical Attribute Sciences (Analytical Operations, Process Development)

Kite Pharma•Santa Monica, CA

2d•$153,935 - $199,210•Onsite

About The Position

The Senior Scientist – Biophysical Attribute Sciences (Analytical Operations, Process Development) position is a site-based role at our Santa Monica, CA location. 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.

Requirements

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
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.
Strong data analysis and problem-solving abilities, including familiarity with data processing software (e.g. statistical tools, visualization).
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.
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.
Evidence of successfully leading projects or technical initiatives with minimal supervision, and providing guidance or mentorship within a team setting.

Nice To Haves

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.
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.
Demonstrated ability to troubleshoot complex technical issues in analytical assays, and to introduce new technologies or innovative approaches for improved biophysical characterization.
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.

Responsibilities

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).
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.
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.
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.
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.
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.
Lead technical projects or components of programs to successful completion, coordinating team efforts to meet project milestones, and introducing innovative analytical approaches.
Serve as technical resources to colleagues across the department, contributing new ideas that can influence project or departmental strategy.
Mentor junior team members and help enhance team capabilities.