{"id":1431106,"url":"https://alion.io/job/gilead-sciences-sr-manager-regulatory-affairs-cmc-2","title":"Sr Manager, Regulatory Affairs CMC","company":{"id":8130,"name":"Gilead Sciences","domain":"gilead.com","url":"https://alion.io/company/gilead","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":12,"ghost_share":0,"stale_share":0.333,"repost_share":0.167,"time_to_fill_p50_days":41,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Santa Monica, United States","Foster City, United States","Thousand Oaks, United States","El Segundo, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":143225,"max":185350,"currency":"USD","period":"year","gross":null,"usd_annual":185350},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-28T00:00:00Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-31T18:22:51Z","board_verified":true,"closed_at":null,"days_open":33,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":33},"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.\nJoin Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.\nWe 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.\nJob Description\nKite 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.\nKey Responsibilities\nRegulatory Strategy and Program Leadership\nLead 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.\nServe 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.\nDefine 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.\nEnsure 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.\nT-cell Drug Product Manufacturing\nProvide 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. \nAssess process changes involving manufacturing scale, equipment, automation, closed processing, hold times, manufacturing duration, formulation, cryopreservation, shipping configuration, raw materials, and critical suppliers.\nGuide 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.\nProvide 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. \nSupport site additions, tech transfers, manufacturing network expansion, process performance qualification, comparability, validation, and post-approval change strategies for T-cell manufacturing and testing sites.\nLentiviral Vector Manufacturing\nProvide 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.\nAssess 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.\nGuide 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.\nDevelop 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.\nSupport 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.\nEarly-Stage Programs\nDefine 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.\nAdvise on comparability and clinical bridging needs for rapid process evolution, analytical method changes, new suppliers, site additions, scale changes, and manufacturing platform improvements.\nEnsure early development plans generate the process understanding, analytical capability, stability data, and manufacturing history needed to support pivotal development and future marketing applications.\nPrepare and critically review CMC content for initial submissions, amendments, substantial modifications, health authority questions, and early scientific advice or regulatory meetings.\nLate-Stage, Registration, and Commercial Lifecycle\nDrive 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.\nEnsure consistency and traceability across Module 3, regional application forms, commitments, responses, validation documentation, inspection materials, and registered manufacturing/testing details.\nLead 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.\nAssess 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.\nSupport pre-approval and routine inspection readiness by aligning regulatory filings with site practices, validation status, manufacturing history, deviations and investigations, quality systems, and commitments.\nSubmission Execution and Functional Excellence\nAuthor, coordinate, and critically review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and post-approval commitments.\nMaintain accurate registered details, regulatory commitments, health authority correspondence, key assumptions, and decision history in approved systems and repositories.\nPresent 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.\nContribute to templates, playbooks, precedents, intelligence, and training that strengthen Regulatory CMC capability for cell therapy and LVV products; coach less experienced colleagues as appropriate.\nBasic Qualifications\nBachelor’s degree and Eight Years' Experience\nOR\nMaster’s degree and Six Year's Experience\nOR\nPhD\nPreferred Qualifications\nDegree 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.\nPharmD or PhD in a scientific discipline and 2+ years of relevant experience.\nSignificant Regulatory Affairs CMC experience in biotechnology or biopharmaceutical development, with direct experience supporting cell therapy and/or viral vector programs.\nHands-on experience with both autologous T-cell drug product manufacturing and LVV manufacturing is strongly preferred.\nExperience across multiple development stages, including early clinical development and pivotal, registration, commercial, or post-approval programs.\nExperience with global submissions and health authority interactions involving process changes, comparability, specifications, analytical method qualification/validation, process validation, stability, and manufacturing site changes.\nExperience with multi-site manufacturing networks, technology transfers, external manufacturers/testing laboratories, inspection readiness, and global change management.\nStrong working knowledge of GMP and relevant ICH and regional requirements for ATMPs/cell and gene therapy products.\nStrong understanding of global CMC regulatory expectations for cell and gene therapy products from first-in-human development through commercialization and lifecycle management.\nTechnical understanding of autologous T-cell unit operations, individualized manufacturing controls, chain of identity/custody, cryopreservation, product testing, comparability, and site/network changes.\nTechnical 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.\nAbility 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.\nAbility to critically evaluate development, characterization, validation, comparability, stability, and manufacturing data; identify gaps; and recommend practical evidence-generation or health authority engagement plans.\nDemonstrated ability to author and review high-quality CMC submissions and communicate complex issues clearly to technical teams, leadership, and health authorities.\nCore Capabilities and Leadership Impact\nOperates with considerable independence and sound judgment across assigned T-cell and LVV workstreams.\nBalances strategic thinking with detailed execution and can manage parallel priorities across early- and late-stage programs.\nBuilds alignment across technical and business functions, constructively challenges assumptions, and drives timely, risk-based decisions.\nCommunicates complex regulatory issues with clarity, executive presence, and appropriate escalation of impact and options.\nLeads selected Regulatory CMC sub-teams or special initiatives and coaches colleagues through technical and regulatory problem-solving.\nModels integrity, accountability, collaboration, inclusion, and a strong commitment to patients and product quality.\nPeople Leader Accountabilities:\nCreate Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. \nDevelop 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. \nEmpower 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. \nThe 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. 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