Technical Development Principal Scientist

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.

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