Experienced Scientist, Biotherapeutics RD (CAR-T)

Location: Spring House, Pennsylvania, United States of America; hybrid

Company

Johnson & Johnson develops healthcare solutions and medicines through its Innovative Medicine and MedTech organizations.

What you will do

• Lead clinical cell therapy manufacturing operations for autologous CAR-T products in Phase 1/2a clinical trials.
• Coordinate production activities, maintain schedules, and communicate operational status to stakeholders and management.
• Author and review SOPs, technical documents, batch records, and logbooks.
• Troubleshoot process and equipment issues and support investigations into deviations and atypical events.
• Drive safety, environmental, quality, compliance, and process improvements through the change control system.
• Train new operations staff and serve as a subject matter expert during internal and external regulatory audits.

Requirements

• Bachelor’s degree or higher.
• At least 5 years of experience in CAR-T or cell/gene therapy GMP manufacturing using single-use vessels and automated cell processing or expansion equipment.
• Experience leading or directing operators manufacturing GMP CAR-T or cell/gene therapy products.
• Knowledge of cGMP regulations, FDA guidance, ATMP requirements, and Annex 1.
• Experience with aseptic processing simulation, staff training, real-time problem solving, and coordination with management and QA.
• Strong communication, analytical reasoning, Microsoft Office, and risk-based innovation skills.

Nice to have

• Experience with SAP, MES/PAS-X, LIMS, project leadership, or change control.

Culture & Benefits

• Inclusive work environment focused on respect, diversity, and individual contribution.
• Work in a team supporting the development of medicines for clinical trials.
• Equal employment opportunity and an interview process with accommodation support for applicants with disabilities.