Scientist/Senior Scientist Process Science

Role Summary

We are seeking a highly motivated PhD-level Immunologist to join our Manufacturing team as a Process Scientist for CAR T cell production. The role focuses on both late stage clinical programs and commercial-scale manufacturing of CAR T cell products, with the primary focus on approved products. The successful candidate will leverage strong immunology expertise along with hands-on experience in GMP manufacturing environments to support and optimize CAR T cell manufacturing processes.

Responsibilities

• Serve as technical subject matter expert in immunology and CAR T cell biology for manufacturing teams.
• Monitor and analyze data from manufacturing processes for CAR T cell products in GMP-compliant facilities.
• Develop, optimize, and troubleshoot CAR T cell manufacturing protocols, including cell isolation, activation, transduction, expansion, and final formulation to optimize them based on T cell biology.
• Collaborate closely with cross-functional teams in Process Development, Quality Control, and Quality Assurance to ensure robust and compliant manufacturing processes.
• Support regulatory submissions by preparing relevant process descriptions and data summaries.
• Identify and implement process improvements to enhance product quality, consistency, and efficiency.
• Participate in deviation investigations and continuous improvement initiatives.

Qualifications

• PhD in Immunology, Cell Biology, or related discipline.
• Hands-on experience with advanced cell culture and immunological techniques (e.g., flow cytometry, cell sorting, viral transduction, functional assays).
• Minimum 2 years' experience (post-PhD) in a GMP-regulated cell therapy, biotech, or pharmaceutical manufacturing environment (GMP experience preferred but not required).
• Demonstrated expertise in T cell biology and adoptive cell therapy process development or manufacturing.
• Strong understanding of GMP regulations and documentation requirements.
• Excellent written and verbal communication skills.
• Detail-oriented, organized, and able to work both independently and collaboratively.

Skills

• Immunology and CAR T cell biology
• GMP manufacturing and regulatory documentation
• Data analysis and interpretation in manufacturing settings
• Process development and optimization
• Cross-functional collaboration

Education

• PhD in Immunology, Cell Biology, or related discipline.