Summary
The role involves designing and implementing early-stage manufacturing processes for CAR T-cell products, ensuring a smooth transition to Late Stage Process Development. The position requires cross-functional collaboration to support product development, manufacturing, and delivery.
Key Responsibilities
* Develop cell manufacturing processes from proof of concept to early-stage development and transition to late-stage and commercial launch.
* Create and manage CMC work packages for regulatory filings (Phase 1 to CTA), including presenting to regulatory bodies.
* Oversee internal reports, regulatory documentation, and technology transfers.
* Co-lead Analytical Strategy development with Analytical Development teams.
* Build and lead the Cell Process Development function, focusing on strategy and innovation.
* Collaborate with internal and external teams to integrate advanced technologies and next-generation CAR T-cell processes.
* Stay updated on new technologies and industry advancements.
* Ensure health and safety compliance and adaptability in a fast-paced environment.
Essential Skills and Experience
* Experience in pharma/biotech development and advancing biological products to clinical trials.
* Expertise in cell/gene therapy process development and GMP manufacturing principles.
* Converting products from initial concept through to commercial launch.
Preferred Qualifications
* BSc in Biochemical or Chemical Engineering (essential); MSc or PhD/EngD preferred.
* Certifications in Chemical Engineering, Quality Engineering, or Six Sigma (preferred).
This role is instrumental in driving the development and commercialization of CAR T-cell therapies, with opportunities for collaboration, leadership, and innovation.
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