Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, Foster City, CA or El Segundo, CA office beginning in January 2027. While this role will 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.

Key Responsibilities

Regulatory Strategy and Program Leadership

• Lead or support integrated global CMC regulatory strategies for both T-cell drug product and LVV, with clear differentiation between early-stage, pivotal/late-stage, registration, and post-approval expectations.
• Serve as the Regulatory CMC representative on program and technical teams; convert program decisions into regulatory requirements, submission plans, health authority engagement strategies, risks, mitigations, and decision points.
• Define phase-appropriate CMC content and evidence expectations, while proactively identifying activities that must mature before pivotal studies, BLA/MAA filing, launch, or post-approval implementation.
• Ensure regulatory strategies consider the end-to-end product relationship, including how LVV quality, variability, changes, and supply continuity may affect T-cell manufacturing performance and final drug product quality.

T-cell Drug Product Manufacturing

• Provide regulatory guidance for autologous T-cell manufacturing processes, including starting material receipt, cell selection/activation, transduction, expansion, harvest, formulation, fill/finish, cryopreservation, storage, shipping, and chain-of-identity/chain-of-custody controls.
• Assess process changes involving manufacturing scale, equipment, automation, closed processing, hold times, manufacturing duration, formulation, cryopreservation, shipping configuration, raw materials, and critical suppliers.
• Guide development and lifecycle management of the T-cell control strategy, including critical quality attributes, critical process parameters, in-process controls, release and stability specifications, potency, identity, purity, viability, safety testing, and comparability acceptance criteria.
• Provide regulatory input on manufacturing success-rate considerations, deviations, out-of-specification or atypical results, process robustness, facility controls, contamination control, and inspection-readiness narratives relevant to individualized patient manufacturing.
• Support site additions, tech transfers, manufacturing network expansion, process performance qualification, comparability, validation, and post-approval change strategies for T-cell manufacturing and testing sites.

Lentiviral Vector Manufacturing

• Provide regulatory guidance for LVV manufacture from plasmid/raw-material controls and cell-bank systems through upstream production, harvest, clarification, purification, concentration, formulation, filling, storage, and shipment.
• Assess LVV process and analytical changes involving producer platform or cell substrate, plasmids, transfection materials, media and raw materials, bioreactor scale or mode, purification steps, formulation, container closure, manufacturing sites, testing sites, and critical suppliers.
• Guide the LVV control strategy, including identity, vector genome titer, infectious titer, potency or functional activity, purity, residuals, replication-competent lentivirus testing, adventitious agent safety, sterility, endotoxin, appearance, stability, and reference standard strategy, as applicable.
• Develop regulatory approaches for LVV comparability and bridging, including assessment of the impact of vector changes on transduction performance, T-cell process performance, and final T-cell drug product quality.
• Support regulatory strategies for LVV process validation, analytical method qualification/validation, reference standards, shelf-life establishment, shipping validation, site transfers, scale-up, capacity expansion, and supply continuity.

Early-Stage Programs

• Define phase-appropriate IND/CTA CMC packages for T-cell and LVV, including clear identification of knowledge gaps, provisional controls, development commitments, and risk-based justifications.
• Advise on comparability and clinical bridging needs for rapid process evolution, analytical method changes, new suppliers, site additions, scale changes, and manufacturing platform improvements.
• Ensure early development plans generate the process understanding, analytical capability, stability data, and manufacturing history needed to support pivotal development and future marketing applications.
• Prepare and critically review CMC content for initial submissions, amendments, substantial modifications, health authority questions, and early scientific advice or regulatory meetings.

Late-Stage, Registration, and Commercial Lifecycle

• Drive CMC readiness for pivotal studies and BLA/MAA submissions, including process characterization, control strategy maturity, analytical validation, specification justification, comparability, process validation, stability, shipping validation, and commercial site readiness.
• Ensure consistency and traceability across Module 3, regional application forms, commitments, responses, validation documentation, inspection materials, and registered manufacturing/testing details.
• Lead or support CMC responses to information requests, deficiency letters, and health authority meeting questions, with clear scientific rationale, risk assessment, data commitments, and executable timelines.
• Assess post-approval changes and change controls for global reporting category, data requirements, implementation timing, market impact, and opportunities for regulatory reliance, grouping, harmonization, or comparability protocols.
• Support pre-approval and routine inspection readiness by aligning regulatory filings with site practices, validation status, manufacturing history, deviations and investigations, quality systems, and commitments.

Submission Execution and Functional Excellence

• Author, coordinate, and critically review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and post-approval commitments.

• Maintain accurate registered details, regulatory commitments, health authority correspondence, key assumptions, and decision history in approved systems and repositories.

• Present concise status, risks, options, and recommendations to technical teams and leadership; escalate issues that may affect clinical supply, pivotal timelines, filing readiness, approval, launch, or continuity of commercial supply.

• Contribute to templates, playbooks, precedents, intelligence, and training that strengthen Regulatory CMC capability for cell therapy and LVV products; coach less experienced colleagues as appropriate.

Basic Qualifications

Bachelors degree and Eight Years' Experience

OR

Masters degree and Six Years Experience
OR

PhD

Preferred Qualifications

• Degree in a scientific discipline and 8+ years of relevant experience; or a degree in life sciences, biotechnology, pharmaceutical sciences, chemistry, biochemical/chemical engineering, or a related field.
• PharmD or PhD in a scientific discipline and 2+ years of relevant experience.
• Significant Regulatory Affairs CMC experience in biotechnology or biopharmaceutical development, with direct experience supporting cell therapy and/or viral vector programs.
• Hands-on experience with both autologous T-cell drug product manufacturing and LVV manufacturing is strongly preferred.
• Experience across multiple development stages, including early clinical development and pivotal, registration, commercial, or post-approval programs.
• Experience with global submissions and health authority interactions involving process changes, comparability, specifications, analytical method qualification/validation, process validation, stability, and manufacturing site changes.
• Experience with multi-site manufacturing networks, technology transfers, external manufacturers/testing laboratories, inspection readiness, and global change management.
• Strong working knowledge of GMP and relevant ICH and regional requirements for ATMPs/cell and gene therapy products.
• Strong understanding of global CMC regulatory expectations for cell and gene therapy products from first-in-human development through commercialization and lifecycle management.
• Technical understanding of autologous T-cell unit operations, individualized manufacturing controls, chain of identity/custody, cryopreservation, product testing, comparability, and site/network changes.
• Technical understanding of LVV upstream and downstream manufacturing, raw materials and plasmids, cell banks, viral safety, vector-specific analytical methods, potency, titer, purity, residuals, stability, and reference standards.
• Ability to connect LVV attributes and process changes to T-cell manufacturing performance and final drug product quality, and to translate these relationships into risk-based regulatory strategies.
• Ability to critically evaluate development, characterization, validation, comparability, stability, and manufacturing data; identify gaps; and recommend practical evidence-generation or health authority engagement plans.
• Demonstrated ability to author and review high-quality CMC submissions and communicate complex issues clearly to technical teams, leadership, and health authorities.

Core Capabilities and Leadership Impact

• Operates with considerable independence and sound judgment across assigned T-cell and LVV workstreams.
• Balances strategic thinking with detailed execution and can manage parallel priorities across early- and late-stage programs.
• Builds alignment across technical and business functions, constructively challenges assumptions, and drives timely, risk-based decisions.
• Communicates complex regulatory issues with clarity, executive presence, and appropriate escalation of impact and options.
• Leads selected Regulatory CMC sub-teams or special initiatives and coaches colleagues through technical and regulatory problem-solving.
• Models integrity, accountability, collaboration, inclusion, and a strong commitment to patients and product quality.

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