Technical Development Principal Scientist
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-09-21
Listing for:
The Fountain Group
Full Time
position Listed on 2026-09-21
Job specializations:
-
Research/Development
Research Scientist, Data Scientist, Pharmaceutical Science/ Research
Job Description & How to Apply Below
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.
- 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.
- 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.
- 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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