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

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Job Description

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 Scient