Technical Development Principal Scientist

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. Lead analytical method development, transfer, qualification, validation, and lifecycle management activities supporting process development, product release, characterization, and stability.

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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