Experienced Scientist, Biotherapeutics RD

Role: Experienced Scientist, Biotherapeutics R&D at Johnson & Johnson, leading the manufacturing team for autologous CAR-T products in Phase 1/2a clinical trials. Responsibilities include overseeing on-the-floor cGMP cell therapy manufacturing, troubleshooting process/equipment issues, authoring technical documents, ensuring compliance with safety, quality, and regulatory standards, and supporting audits. The role also involves training staff, driving process improvements, and serving as SME during regulatory inspections. Qualifications: Bachelor’s degree with at least 5 years of GMP experience in CAR-T or cell/gene therapy manufacturing, leadership in GMP environments, and knowledge of FDA and international regulations for cell-based products. Preferred skills include project management, experience with SAP, MES, LIMS, and change control systems. High-value specifics: focus on autologous CAR-T production, Phase 1/2a clinical trials, sterile/aseptic processing, and regulatory audit support. Location: Spring House, PA, with a requirement for on-site work.