Technical Development Principal Scientist

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

Job Title: Technical Development Scientist III / Technical Development Principal Scientist

Location: San Diego, CA — Onsite

Pay Rate: $55.17–$68.97/hour

Job Description

• Develop, optimize, and adapt analytical methods for cell therapy product characterization and release using Design of Experiments (DoE).
• Design and execute exploratory studies to define Critical Quality Attributes (CQAs) and improve analytical methods.
• Lead analytical method development, transfer, qualification, validation, and lifecycle management activities supporting process development, product release, characterization, and stability.
• 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 analytical and process development activities.
• Support technology transfer of analytical methods to QC laboratories and ensure methods are fit-for-purpose.
• Author SOPs, assay development and qualification reports, and regulatory documentation supporting CMC and regulatory filings.
• Apply analytical development expertise to cell therapy products, including stem cell and T-cell platforms.

Education

• Master's degree in Immunology, Molecular Biology, Biochemistry, or related scientific discipline with 6–9+ years of analytical development, QC, technology transfer, or method lifecycle management experience.
• OR Ph.D. in Immunology, Molecular Biology, Biochemistry, or related scientific discipline with 2+ years of industry experience.

Required Skills

• Flow cytometry and immunology analytical method development.
• Analytical method transfer to QC laboratories.
• Cell therapy analytical development and product characterization.
• Analytical method optimization, remediation, qualification, and validation.
• CMC technology transfer and analytical control strategies.
• Design of Experiments (DoE), experimental design, and analytical data analysis.
• Control charts and process/analytical capability assessments.
• ICH guidelines, cGMP, USP, and regulatory requirements applicable to analytical development and method qualification/validation.
• Analytical method lifecycle management and assay trending.

Preferred Skills

• 2+ years of cell therapy industry experience.
• Analytical control systems for stem cell and T-cell products.
• ddPCR, qPCR, cell imaging, reporter-based potency assays, cell engineering, Next-Generation Sequencing (NGS), or metabolic analysis.
• Experience supporting cell therapy CMC and regulatory filings.