onsite
Director, CAR T Manufacturing Systems & Strategy - 6062-Janssen Pharmaceuticals Legal Entity
Software Engineer
Leads strategy and implementation of CAR‑T cell therapy manufacturing systems, driving automation, GMP compliance, and data‑driven process optimization across the production lifecycle.
About the role
Key Responsibilities
- Define and execute the long‑term manufacturing strategy for CAR‑T cell therapies, aligning technology roadmaps with business objectives.
- Lead design, qualification, and scale‑up of automated bioprocessing platforms, ensuring compliance with GMP and regulatory standards.
- Partner with R&D, supply chain, and quality teams to translate process innovations into robust, reproducible manufacturing workflows.
- Drive data‑analytics initiatives to monitor process performance, identify improvement opportunities, and support continuous process verification.
- Manage cross‑functional project teams, budgets, and timelines to deliver system upgrades and new facility capabilities on schedule.
Requirements
- Advanced degree (PhD, MS, or equivalent) in Biochemical Engineering, Cell Therapy, or a related field with 10+ years of experience in biologics manufacturing.
- Proven expertise in CAR‑T or other cell‑based therapy production, including process development, scale‑up, and technology transfer.
- Strong knowledge of GMP, FDA/EMA regulations, and validation practices for sterile manufacturing environments.
- Hands‑on experience with automation, control systems, and data‑analytics tools to drive process optimization.
- Demonstrated leadership in managing large, multidisciplinary projects and teams in a fast‑paced, innovative setting.