Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
The Senior Director of Manufacturing leads our cell therapy manufacturing organization through the transition from clinical-stage to commercial operations. The Senior Director owns GMP manufacturing execution across the product lifecycle, including facility and process readiness for BLA submission and pre-license inspection (PLI), and the build of a scalable, inspection-ready commercial manufacturing organization. This is a hands-on leadership role for someone who has taken an autologous cell therapy through late-stage clinical manufacturing and into licensure and launch.
KEY ROLE AND RESPONSIBILITIES:
Commercial Readiness and Launch
- Lead manufacturing readiness for BLA filing, PLI, and commercial launch, including facility qualification, process performance 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.
GMP Manufacturing Operations
- 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.
- Strong scientific background and expertise in cell culture products - prior experience in cell or tissue therapy
- Demonstrated experience in process characterization and product development, technology transfer, continuous improvement and change management
Process Robustness and Continuous Improvement
- Partner with Process Development and MSAT to ensure process transfer, scale-up, comparability, and lifecycle management.
- 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).
People and Organization
- Build, scale, and mentor a high-performing organization (Directors/Associate Directors, Managers, Supervisors, and operators), including shift structure and staffing models for 24/7 operations if needed.
- Establish a culture of quality, accountability, safety, and patient focus.
- Develop training, qualification, and succession programs.
Cross-Functional Leadership and Governance
- Serve as a member of 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 (CMC Section 3.2.P) to regulatory filings and support health authority interactions, with appropriate Regulatory and Quality review.
- Oversee relationships with critical suppliers and external manufacturing partners.
PREFERRED EDUCATION:
- 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
PREFERRED 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 the 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
KNOWLEDGE, SKILLS AND ABILITIES:
- Excellent oral and written communication skills
- Ability to work independently and collaboratively among cross-functional teams
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
- Excellent analytical skills and scientific/technical expertise
The salary range for this position is $220,000 to $300,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
