Technical Development Principal Scientist

IT Engagements is a global staff augmentation firm providing talent on-demand and total workforce solutions for one of our premium clients in San Diego, CA.

About the role

We are seeking an experienced and motivated Scientist III to join the Analytical Development team in San Diego. This position works with the PTCC team to develop robust analytical methods for cell product characterization and release. The successful candidate will critically evaluate scientific data and study protocols, lead initiatives, and act as a subject matter expert in cross-functional teams. This individual will ensure that analytical methods and data are fit-for-purpose in a fast-paced and dynamic environment.

Responsibilities

• Develop or adapt analytical methods for cell therapy product release and characterization by designing and executing studies via design of experiment (DoE).
• 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 interdepartmental 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.
• Perform data analysis, document study outcomes, and present conclusions to key stakeholders.
• Design, execute, and approve method development, transfer, and qualification in support of process development, product characterization, product release, and stability.
• Lead lifecycle management of analytical assays by trending data and assigning appropriate controls.
• Author SOPs, assay development and qualification reports, and regulatory documents.
• Ensure adherence to high technical standards and compliance with applicable regulatory guidelines for analytical data supporting regulatory filings.
• Work with cross-functional teams to advance development of cell therapy products.
• Support training of junior Research Associates or other team members, as needed.

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.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.
• Excellent interpersonal, verbal, and written communication skills.
• Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description.
• Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams.
• Strong critical thinking, troubleshooting, and problem-solving skills.
• Attention to safety, good laboratory practice, and good documentation practice.

Preferred Qualifications

• Two or more years of relevant cell therapy industry experience.
• Experience with analytical control systems for stem cell and T cell products.
• Experience with one or more of the following analytical techniques: ddPCR, qPCR, cell imaging, reporter-based potency, cell engineering, Next-Generation Sequencing, and metabolic analysis.