Technical Development Principal Scientist

San Diego, CA

About the role

Develop or adapt analytical methods for cell therapy product release and characterization by designing and executing studies via design of experiment (DoE).

Responsibilities

• Design and execute exploratory experiments to better understand and define Critical Quality Attributes (CQAs) and optimize current analytical methods.
• Independently research, plan, and execute experiments; analyze data to determine next steps and make recommendations to internal and inter-departmental audiences.
• Perform risk and gap assessments for analytical methods to enhance compliance and robustness.
• Execute routine laboratory experiments in collaboration with junior technical staff to generate high-quality data following best practices for assay and instrument operations.

Requirements

• Master’s degree with 6–9+ years of experience in analytical development, QC, technology transfer, and method lifecycle management, or Ph.D. in a relevant scientific discipline (e.g., Immunology, Molecular Biology, Biochemistry, or related field) with 2+ years of industry experience.
• Expertise in flow cytometry and immunology analytical method development, including method transfer to QC labs.
• Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies, and method qualification/validation.
• Demonstrated proficiency in experimental design, data analysis, control charts, and capability assessments using Design of Experiments (DoE).
• Ability to interpret and apply ICH guidances, cGMP, USP, regulatory requirements, and industry best practices for analytical method development, technology transfer, method qualification/validation, and process development.

Benefits

• Medical insurance (PPO, HMO) and dental & vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay

$115,565 – $144,435 (dependent on experience)