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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr
