Senior Scientist, In-vivo CAR-T
Johnson & Johnson Innovative Medicine · Spring House, PA · 1 mo ago
HybridFull-time
Purpose
The Senior Scientist will support the development, optimization, and scale-up of lentiviral vector (LVV) drug product processes from early to late-stage development. The role combines hands-on laboratory work with strong cross-functional collaboration to ensure robust, scalable, and GMP-ready processes.
Key Responsibilities
- Design and execute LVV process development studies across early and late development stages
- Collaborate with modelling experts, data scientists to identify opportunities where modelling or machine learning can reduce experimental burden, improve robustness, or define process design space
- Perform hands-on laboratory work including process design, optimization, and characterization
- Analyze and interpret data to support process understanding, optimization, and decision-making
- Support process characterization activities, including identification of CPPs and development of robust processes
- Contribute to scale-up and manufacturing readiness, including support of technology transfer to internal sites or CMOs
- Collaborate cross-functionally with Analytical Development, MSAT, Quality, Manufacturing, and Regulatory teams to ensure alignment on process strategy and execution
- Document experimental work and results in accordance with GxP and data integrity requirements
- Participate in troubleshooting activities and continuous process improvement initiatives
Qualifications
- Ph.D. 0-2 years' experience, B.S. or M.S. with 4-6 years' experience in an appropriate scientific discipline (Life Sciences or Chemical Engineering) is required
- Relevant experience in process development of viral vectors and/or LVV formulation development
- Strong hands-on laboratory experience in drug product or viral vector development
- Understanding of process scale-up, technology transfer, and GxP principles
- Strong scientific problem-solving and data interpretation skills
- Hands-on, proactive, and detail-oriented approach
- Ability to work effectively in a cross-functional, matrixed environment
- Clear and concise communication skills (written and verbal)
- Ability to manage multiple priorities in a dynamic development environment
Preferred Experience
- Experience with LVV platforms, viral vectors and/or advanced therapies
- Familiarity with process validation (e.g., LCPV) and manufacturing support
- Exposure to both early and late-stage development or commercial readiness activities