Senior Scientist, Allogeneic T-Cell Therapy Process Development

Main Duties & Responsibilities

This position will involve a substantial amount of hands-on cell culture work, including human CAR-T and TCR-T cell generation, in vitro expansion, scale-up, and characterization of culture processes. The role will require performing gene editing activities and manipulation of human primary cells, while applying strong scientific judgment to support process optimization, process characterization, and development of scalable manufacturing approaches.

As a Senior Scientist, you will independently own the design, execution, analysis, interpretation, and documentation of process development studies. You will be expected to lead studies with minimal supervision, use data-driven decision-making to guide next steps, troubleshoot technical challenges, and contribute to the overall technical strategy for allogeneic CAR-T and TCR-T process development.

This role will also require close cross-functional collaboration with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and other partner functions to support process understanding, technology transfer, and clinical manufacturing readiness. In addition, you will provide scientific guidance and mentorship to junior scientists and associates.

• Support tech transfer activities such as batch record and SOP development, real-time troubleshooting, investigation and impact assessment of deviations, change control management, process monitoring and data analysis, and risk assessments.
• Author and contribute to development reports, scientific publications, patents, and regulatory filings in different countries and regions.
• Position may require traveling domestically and abroad.

Required Skills

• Experience culturing human primary cells (T cell culture experience necessary).
• Knowledgeable about upstream and downstream process development for cell therapies both laboratory based and tech transfer based.
• Strong flow cytometry T cell characterization experience.
• Experience engineering cells in scale-up processes with manufacture-ready genome editing tools and DNA/RNA transfection approaches.
• Familiar with the fundamentals of DOE.
• Strong background in experimental design and data analysis skills are essential.
• Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
• Excellent teamwork and communication skills including proven technical writing skills are required.
• Position may require weekend work.

Desired Skills

• Knowledge about immunology is highly desirable.
• Experience with cell editing technologies: CRISPR/Cas9, base editing, etc.
• Experience with viral transduction techniques desirable.
• GMP experience preferred.
• Experience with cell characterization (dPCR, ELISA, NGS) ideal.
• Scientific rigor in assessing own data and that of others.
• Utilizes forward-looking perspective to contribute to 'go/no go' decisions.

Education / Experience

BS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology, or related field with > 6 years of relevant experience or MS degree with a minimum of 4 years or PhD with a minimum of 1 year of relevant proven experience.