Sr Manager, Regulatory Affairs CMC

Job Description 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. 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; elevate 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 Bachelor’s degree and Eight Years' Experience OR Master’s degree and Six Year's Experience OR PhD and Two Year's Experience 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 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: $143,225.00 - $185,350.00. 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: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit Sign up to follow @KitePharma on Twitter at For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact View email address on click.appcast.io for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. #J-18808-Ljbffr Gilead Sciences Inc.