Regulatory CMC Lead for T-Cell & LVV Therapies

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

Benefits offered by this job

Medical insurance

Dental coverage

Vision insurance

Life insurance

Job summary

Kite Pharma, Inc. is relocating staff as it shifts headquarters and expands its California footprint. The role sits in Santa Monica with planned relocation options to Thousand Oaks, Foster City, or El Segundo beginning January 2027.

The company supports a flexible policy with two days of remote work and three onsite days. The successful candidate will lead regulatory CMC strategies for autologous T-cell products and LVV, guide lifecycle management, and ensure readiness for pivotal and

Qualifications

• Bachelor’s degree and Eight Years' Experience
• OR Master’s degree and Six Year's Experience
• OR PhD

Responsibilities

• Lead or support integrated global CMC regulatory strategies for T-cell drug product and LVV.
• Serve as Regulatory CMC representative on program teams and define regulatory requirements.
• Define phase-appropriate CMC content and evidence expectations for pivotal studies and filings.
• Provide regulatory input on manufacturing changes, comparability, and post-approval changes.
• Support submission execution and regulatory readiness across INDs, CTAs, BLAs, MAAs.

Skills

T-cell manufacturing

LVV manufacturing

GMP knowledge

Regulatory strategy

Education

Bachelor’s degree + 8 years experience

Master’s degree + 6 years experience

PhD

Job description

Kite Pharma, Inc. is relocating staff as it shifts headquarters and expands its California footprint. The role sits in Santa Monica with planned relocation options to Thousand Oaks, Foster City, or El Segundo beginning January 2027.

The company supports a flexible policy with two days of remote work and three onsite days. The successful candidate will lead regulatory CMC strategies for autologous T-cell products and LVV, guide lifecycle management, and ensure readiness for pivotal and