Senior Scientist, Analytical Development - Cell Therapy

6AM City, LLC; California (MO); On-site; USD 140,000 - 210,000; Full time

Job summary

6AM City, LLC is seeking a Technical Development Principal Scientist to lead analytical development for cell therapy products. The role focuses on creating robust analytical methods, characterizing products, and supporting release and stability programs.

You will act as a SME on cross-functional teams and drive innovation in analytics. The candidate will lead method lifecycle management, transfer, and qualification activities, while mentoring junior staff and ensuring regulatory alignment.

Qualifications

• Master’s degree with 6–9 years in analytical development or PhD with 2+ years in industry.
• Expertise in flow cytometry and immunology for analytical method development and transfer to QC labs.
• Leadership in method optimization, remediation, and method qualification/validation.
• Proficiency with experimental design, data analysis, control charts, and DoE.

Responsibilities

• Develop and adapt analytical methods for cell therapy product release and characterization by DoE studies.
• Define CQAs and optimize analytical methods through exploratory experiments.
• Plan, perform, analyze experiments, and present findings to stakeholders.
• Perform risk and gap assessments to improve compliance, robustness, and reliability.
• Collaborate with junior staff to ensure high-quality data and SOPs.
• Lead method development, transfer, qualification, and lifecycle management.
• Document outcomes and conclusions; summarize for regulatory filings as needed.
• Maintain safety, GLP, and GDP in all activities.
• Support cross-functional teams in advancing cell therapy products.

Skills

Flow cytometry

Immunology

DoE

Data analysis

ICH guidance & cGMP

Regulatory awareness

Project management

Communication skills

Education

Master’s degree in Immunology/ Molecular Biology/ Biochemistry

PhD in a related field

Tools

Flow cytometer

Job description

6AM City, LLC is seeking a Technical Development Principal Scientist to lead analytical development for cell therapy products. The role focuses on creating robust analytical methods, characterizing products, and supporting release and stability programs.

You will act as a SME on cross-functional teams and drive innovation in analytics. The candidate will lead method lifecycle management, transfer, and qualification activities, while mentoring junior staff and ensuring regulatory alignment.