Principal Scientist, Cell Therapy Analytics

The Fountain Group; Solana Beach (CA); On-site; USD 76,000 - 95,000; Full time

Job summary

The Fountain Group is seeking a Technical Development Scientist III / Principal Scientist in San Diego, onsite, to lead analytical method development for cell therapy products, define CQAs, and oversee method transfer and validation across development and QC labs.

The role requires strong experience in DoE, method lifecycle management, regulatory submissions support, and collaboration with process development and manufacturing teams; a Master’s or PhD and required years of experience are

Qualifications

• Master's or PhD with industry experience in analytical development, QC, tech transfer, or method lifecycle management.
• Master's degree path requires 6–9+ years of experience; PhD path requires 2+ years of industry experience.

Responsibilities

• Develop, optimize, and adapt analytical methods for cell therapy product characterization and release using DoE.
• Design and execute exploratory studies to define CQAs and improve analytical methods.
• Lead analytical method development, transfer, qualification, validation, and lifecycle management activities.
• Perform analytical method risk/gap assessments, remediation, and robustness improvements.
• Establish analytical control strategies, trending approaches, control charts, and capability assessments.
• Analyze experimental data, interpret study outcomes, and develop recommendations for analytics and process development.
• Support technology transfer of analytical methods to QC labs and ensure methods are fit-for-purpose.
• Author SOPs, assay development and qualification reports, and regulatory documentation for CMC filings.
• Apply analytical development expertise to cell therapy products including stem cell and T-cell platforms.

Skills

Flow cytometry analytics

Analytical method transfer

Cell therapy analytics

DoE design and analysis

CMC transfer knowledge

cGMP regulatory knowledge

Data analysis and interpretation

Regulatory filing support

SOP/documentation

Project leadership

Education

Master's degree in Immunology / Molecular Biology / Biochemistry or related field

Ph.D. in Immunology / Molecular Biology / Biochemistry or related field

Job description

The Fountain Group is seeking a Technical Development Scientist III / Principal Scientist in San Diego, onsite, to lead analytical method development for cell therapy products, define CQAs, and oversee method transfer and validation across development and QC labs.

The role requires strong experience in DoE, method lifecycle management, regulatory submissions support, and collaboration with process development and manufacturing teams; a Master’s or PhD and required years of experience are