Scientist/Senior Scientist Process Science

Role Summary

PhD-level Immunologist to join the Manufacturing team as a Process Scientist for CAR T cell production. The role supports late-stage clinical programs and commercial-scale manufacturing of CAR T cell products, with the primary focus on approved products. The successful candidate will combine immunology expertise with hands-on experience in GMP manufacturing environments to 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

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