Senior Director, Manufacturing

Lyell Immunopharma•Bothell, WA

11d

About The Position

The Senior Director of Manufacturing leads Lyell’s cell therapy manufacturing organization through the transition from clinical-stage to commercial operations. This hands-on leadership role owns GMP manufacturing execution across the product lifecycle, including facility and process readiness for BLA submission and pre-license inspection (PLI), and the development of a scalable, inspection-ready commercial manufacturing organization. The role is intended for a leader who has taken an autologous cell therapy through late-stage clinical manufacturing and into licensure and launch. The Senior Director leads manufacturing readiness for BLA filing, PLI, and commercial launch; oversees day-to-day clinical and commercial GMP manufacturing; and partners with Quality, Supply Chain, Process Development, MSAT, Regulatory, Commercial, and external partners. The position builds and mentors a high-performing manufacturing organization, contributes to Technical Operations leadership and executive planning, manages manufacturing budgets and capital projects, and supports regulatory filings and health authority interactions. Lyell is a clinical-stage company developing next-generation CAR T-cell therapies for solid tumors and hematologic malignancies. Its product candidates are designed to create T cells that resist exhaustion and retain durable stemness. Lyell describes its culture as based on Science, Respect, Collaboration, and Courage, and is committed to an open, diverse, and inclusive workplace.

Requirements

At least 15 years of experience in biotechnology bioprocessing, GMP manufacturing, and/or CMC development.
Experience in a GMP manufacturing setting, technology transfer, and implementation of new technologies in a regulated environment.
Cell therapy experience.
Strong scientific background and expertise in cell culture products, with prior experience in cell or tissue therapy.
Demonstrated experience in process characterization and product development, technology transfer, continuous improvement, and change management.
Excellent oral and written communication skills.
Ability to work independently and collaboratively across cross-functional teams.
Ability to work efficiently, prioritize workflow, meet deadlines, and balance competing priorities.
Excellent analytical skills and scientific/technical expertise.

Nice To Haves

BA/BSc in Molecular Biology, Immunology, Biotechnology, or a related discipline with a minimum of 20 years’ experience; or an MBA or MSc in one of these fields or a related discipline with a minimum of 15 years’ experience.
Experience assessing new technologies in a fast-paced learning organization, preferably in a cross-functional setting evaluating impacts across research, development, and commercial organizations.
Prior experience designing, qualifying, or starting up manufacturing facilities.
Experience taking an autologous cell therapy through late-stage clinical manufacturing, licensure, and launch.

Responsibilities

Lead manufacturing readiness for BLA filing, pre-license inspection, and commercial launch, including facility qualification, process performance qualification, and technology transfer from Process Development.
Develop and execute manufacturing strategy, including capacity planning and site expansion.
Partner with Supply Chain, Quality, and Commercial to support reliable vein-to-vein performance, turnaround time, slot scheduling, and patient-specific logistics.
Direct day-to-day clinical and commercial manufacturing in compliance with cGMP, applicable U.S. regulations, and EU/ICH requirements.
Drive right-first-time execution, batch record quality, and on-time batch disposition.
Own manufacturing deviations, CAPAs, and change controls, partnering with Quality Assurance on root cause and effectiveness.
Maintain inspection readiness and serve as a senior representative during regulatory and partner audits.
Partner with Process Development and MSAT on process transfer, scale-up, comparability, and lifecycle management.
Improve manufacturing success rate, cost of goods, and cycle time through lean and operational excellence methods.
Evaluate and implement automation, closed-system processing, and digital manufacturing tools such as MES and electronic batch records.
Build, scale, and mentor a high-performing manufacturing organization, including leadership, managers, supervisors, and operators; develop shift structures and staffing models for 24/7 operations if needed.
Establish a culture of quality, accountability, safety, and patient focus, and develop training, qualification, and succession programs.
Serve on the Technical Operations leadership team and contribute to executive-level planning and decision-making.
Manage the manufacturing budget, headcount planning, and capital projects.
Contribute manufacturing content for CMC Section 3.2.P of regulatory filings and support health authority interactions, with appropriate Regulatory and Quality review.
Oversee relationships with critical suppliers and external manufacturing partners.