Kite Manager, Regulatory Affairs CMC
We're here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in Philadelphia PA, El Segundo, CA or Thousand Oaks, CA.
Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA or El Segundo, CA office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.
Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycle management.
Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements for cell therapy products and associated LVV and critical raw materials.
Assist in execution of global CMC regulatory strategies under guidance of senior staff for both cell therapy products and lentiviral vector manufacturing platforms.
Partner with related to LVV process development, manufacturing, analytical testing, comparability, and supply continuity cross-functional teams (e.g., Process Design, MSAT, Quality, Manufacturing, Supply Chain) to support regulatory deliverables
Support health authority interactions, including preparation of responses to information requests (IRs/RTQs) and meeting materials related to LVV manufacturing processes, control strategy, potency, safety testing, and process validation
Assess change controls for regulatory impact and support lifecycle management activities including changes associated with LVV manufacturing processes, raw materials, analytical methods, manufacturing sites, and production scale.
Support activities related to manufacturing changes, comparability, and site updates or both cell therapy and LVV manufacturing operations.
Contribute to inspection readiness activities, including preparation of supporting documentation for LVV and cell therapy manufacturing facilities.
Maintain accurate regulatory records and documentation in relevant systems related to LVV manufacturing, supply, regulatory compliance, and health authority commitments
Identify and escalate risks and contribute to mitigation strategies focused on evolving global regulatory expectations for gene-modified cell therapies and viral vectors
Participate in continuous improvement initiatives and knowledge-sharing activities
Scope and Impact
Supports regulatory activities for assigned programs under guidance
Contributes to timely delivery of regulatory submissions and responses
Builds foundational expertise in Regulatory CMC
Supports development and execution of regulatory strategies for lentiviral vector manufacturing processes used in commercial and late-stage clinical cell therapy programs.
Contributes to regulatory assessments and risk management activities associated with LVV manufacturing changes, facility transfers, process improvements, and capacity expansion initiatives.
Knowledge, Skills, and Abilities
Foundational knowledge of CMC regulatory requirements and ICH guidelines
Strong written and verbal communication skills
Attention to detail and strong organizational skills
Ability to manage multiple priorities in a fast-paced environment
Effective cross-functional collaboration
Proactive and solution-oriented mindset
Core Competencies
Working knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), and analytical characterization approaches.
Understanding of regulatory expectations for viral vector comparability, process validation, control strategy development, and post-approval lifecycle management.
Knowledge of global regulatory requirements and emerging guidance applicable to cell and gene therapy products, including viral vector starting materials.
Ability to assess manufacturing changes and interpret their potential regulatory impact on LVV quality, safety, potency, and supply continuity
Basic Qualifications
Bachelor's degree with Six Years' experience
OR
Master's degree with Four Years' experience
Preferred Qualifications
- Degree in a scientific discipline
- Experience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control strategies, and lifecycle management
- Experience supporting regulatory submissions and health authority interactions
- Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization.
- Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management
People Leader Accountabilities :
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $133,195.00 - $172,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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