Head of Cell Therapy Manufacturing & Commercial Readiness

Lyell Immunopharma; Bothell (WA); On-site; USD 220,000 - 300,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma is seeking a Senior Director of Manufacturing to lead our cell therapy manufacturing organization as we transition from clinical-stage to commercial operations. You will own GMP manufacturing across the product lifecycle, prepare for BLA submission and regulatory inspections, and build a scalable, inspected-ready manufacturing organization.

You will drive manufacturing strategy, capacity planning, technology transfer, and 24/7 operations readiness, mentoring a senior team and

Qualifications

• BA/BSc in Molecular Biology, Immunology, Biotechnology or related discipline with a minimum of 20 years' experience; or
• MBA or MSc in Molecular Biology, Immunology, Biotechnology or related discipline with a minimum of 15 years' experience
• Minimum of 15+ years of experience in biotechnology bioprocessing, GMP manufacturing and/or CMC development.
• Experience in GMP manufacturing setting, technology transfer and implementation of new technologies in a regulated environment.
• Experience with assessment of new technologies in a fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations
• Prior experience in either design, qualification, start-up of manufacturing facilities
• Cell therapy experience

Responsibilities

• Lead manufacturing readiness for BLA filing, PLI, and commercial launch, including facility qualification, PPQ, and technology transfer from Process Development.
• Develop and execute the manufacturing strategy, including capacity planning and site expansion.
• Partner with Supply Chain, Quality, and Commercial to ensure reliable vein-to-vein performance, including turnaround time, slot scheduling, and patient-specific logistics.
• Direct day-to-day clinical and commercial manufacturing, ensuring compliance with cGMP, 21 CFR Parts 210/211, 600-680, and 1271, and applicable EU/ICH requirements.
• Drive right-first-time execution, batch record quality, and on-time batch disposition.
• Own deviations, CAPAs, and change controls arising from manufacturing, partnering closely with Quality Assurance on root cause and effectiveness.
• Maintain a continuous state of inspection readiness and serve as a senior representative during regulatory and partner audits.
• Lead manufacturing success rate, cost of goods (COGS), and cycle-time improvement through lean/operational excellence methods.
• Evaluate and implement automation, closed-system processing, and digital manufacturing tools (e.g., MES, electronic batch records).
• Build, scale, and mentor a high-performing organization, including shift structure and staffing for 24/7 operations if needed.
• Establish a culture of quality, accountability, safety, and patient focus.
• Develop training, qualification, and succession programs.
• Contribute manufacturing content (CMC Section 3.2.P) to regulatory filings and support health authority interactions.

Skills

Cell therapy

GMP manufacturing

Process transfer

Lean/operational excellence

Cross-functional teamwork

Analytical skills

Communication skills

Education

BA/BSc in Molecular Biology, Immunology, Biotechnology

MBA or MSc in Molecular Biology, Immunology, Biotechnology

Job description

Lyell Immunopharma is seeking a Senior Director of Manufacturing to lead our cell therapy manufacturing organization as we transition from clinical-stage to commercial operations. You will own GMP manufacturing across the product lifecycle, prepare for BLA submission and regulatory inspections, and build a scalable, inspected-ready manufacturing organization.

You will drive manufacturing strategy, capacity planning, technology transfer, and 24/7 operations readiness, mentoring a senior team and