CMC Regulatory Strategy Lead – Cell Therapy

Kite Pharma, Inc.; El Segundo (CA); Hybrid; USD 143,000 - 185,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Benefits package (medical, dental, vis

Life insurance

Job summary

Kite Pharma, Inc. is seeking a Regulatory CMC leader to drive end-to-end regulatory strategies for T-cell and LVV programs.

You will shape governance for regulatory submissions, maintain lifecycle strategies, and partner with manufacturing to ensure compliant, scalable processes across development and commercialization. The role requires extensive experience in biotechnology CMC, with hands-on knowledge of autologous T-cell and LVV manufacturing, and a proven ability to navigate global health

Qualifications

• Bachelor’s degree and eight years’ experience required; advanced degree preferred.
• Significant Regulatory CMC experience in biotechnology or biopharmaceutical development.
• Hands-on experience with autologous T-cell and LVV manufacturing is strongly preferred.

Responsibilities

• Lead regulatory CMC strategies for cell therapy programs across development stages.
• Coordinate global CMC submissions and interact with health authorities.
• Guide lifecycle management, comparability, and post-approval changes for T-cell and LVV products.
• Collaborate cross-functionally to ensure manufacturing readiness and inspection preparedness.

Education

Bachelor’s degree and Eight Years’ Experience

Master’s degree and Six Year’s Experience

PhD

Job description

Kite Pharma, Inc. is seeking a Regulatory CMC leader to drive end-to-end regulatory strategies for T-cell and LVV programs.

You will shape governance for regulatory submissions, maintain lifecycle strategies, and partner with manufacturing to ensure compliant, scalable processes across development and commercialization. The role requires extensive experience in biotechnology CMC, with hands-on knowledge of autologous T-cell and LVV manufacturing, and a proven ability to navigate global health