Principal Scientist, Analytical Development - Cell Therapy

IT Engagements, Inc.; San Diego (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

IT Engagements, San Diego onsite, seeks an experienced Scientist III to join the Analytical Development team. You will develop and implement analytical methods for cell therapy product characterization and release, collaborating with the PTCC and cross-functional partners.

The role emphasizes method lifecycle management, DoE-driven experiments, data interpretation, and regulatory readiness while guiding junior staff in a fast-paced environment.

Qualifications

• Masters or PhD in a relevant scientific discipline (e.g., Immunology, Molecular Biology, Biochemistry) with industry experience.
• Expertise in flow cytometry and immunology analytical method development.
• Leadership in method optimization, technology transfer, and validation.
• Experience with DoE and data analysis to support regulatory filings.

Responsibilities

• Develop or adapt analytical methods for cell therapy product release and characterization via DoE studies.
• Design and execute exploratory experiments to define CQAs and optimize methods.
• Lead data analysis, document outcomes, and present to stakeholders.
• Drive method development, transfer, and qualification in support of development and release.
• Draft SOPs and regulatory documents ensuring compliance with guidelines.

Skills

Flow Cytometry

Immunology

Data Analysis

Team Leadership

DoE

Education

M.S./Ph.D. in relevant science

Job description

IT Engagements, San Diego onsite, seeks an experienced Scientist III to join the Analytical Development team. You will develop and implement analytical methods for cell therapy product characterization and release, collaborating with the PTCC and cross-functional partners.

The role emphasizes method lifecycle management, DoE-driven experiments, data interpretation, and regulatory readiness while guiding junior staff in a fast-paced environment.