Sr Manager, Regulatory Affairs CMC

Summary

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

Job Description
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

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. . click apply for full job details

Job Description

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

Job Description
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

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. . click apply for full job details