Regulatory CMC Lead - Cell Therapy (Hybrid)

Kite Pharma, Inc.; Thousand Oaks (CA); Híbrido; USD 143.000 - 185.000; Jornada completa

Descripción de la vacante

Kite Pharma, Inc. is hiring for a Regulatory CMC leader to drive global CMC strategies for autologous T-cell therapies and LVV programs. The role includes leading submissions, cross‑functional collaboration, and ensuring readiness for pivotal trials and post‑approval changes.

Relocation considerations apply as Kite expands in Southern California and neighboring sites. The position emphasizes regulatory strategy, lifecycle management, and direct engagement with health authorities to enable

Formación

• Basic qualifications include degrees and years of experience in regulatory affairs.
• Preferred qualifications emphasize experience with biotechnology or cell therapy.
• Strong knowledge of GMP and ICH and global CMC expectations.

Responsabilidades

• Lead or support integrated global CMC regulatory strategies for T-cell drug product and LVV.
• Serve as Regulatory CMC representative on program and technical teams; convert decisions into regulatory requirements and plans.
• Define phase-appropriate CMC content and evidence expectations for pivotal studies and filings.
• Ensure regulatory strategies consider LVV quality, changes, and supply continuity affecting T-cell manufacturing.
• Provide regulatory guidance for autologous T-cell manufacturing processes across the lifecycle.
• Assess process changes involving manufacturing scale, automation, and materials.
• Guide development and lifecycle management of the T-cell control strategy and specifications.
• Support site additions, tech transfers, and network expansion within regulatory frameworks.
• Lead or support LVV comparability, bridging, validation, and site transfers.
• Drive submission execution, health authority interactions, and change management.

Conocimientos

CMC regulatory

Regulatory strategy

CMC submissions

Leadership

Educación

Bachelor's degree + 8+ years

Master's degree + 6+ years

PhD in science

PharmD or PhD in life sciences

Descripción del empleo

Kite Pharma, Inc. is hiring for a Regulatory CMC leader to drive global CMC strategies for autologous T-cell therapies and LVV programs. The role includes leading submissions, cross‑functional collaboration, and ensuring readiness for pivotal trials and post‑approval changes.

Relocation considerations apply as Kite expands in Southern California and neighboring sites. The position emphasizes regulatory strategy, lifecycle management, and direct engagement with health authorities to enable