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.
KEY ROLE AND RESPONSIBILITIES:
- Provide phase-appropriate guidance related to CMC regulatory requirements and expectations for cell therapy development
- Ensure timely escalation of critical issues to senior management by leading CMC regulatory risk assessment, identifying key CMC regulatory issues and mitigation activities needed throughout product life cycle
- Collaborate with CMC colleagues to develop CMC content for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications (CTA) and BLA/MAA
- Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and premeeting meeting packages for Regulatory Authority meetings
- Coordinate, manage CMC regulatory projects including management of submission timelines, ensuring that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements
- Maintain knowledge of the regulatory environment, regulations, and procedures. Identify CMC regulatory opportunity and risks across development lifecycle
- Partner with key stakeholders in developing tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies
PREFERRED EDUCATION:
- MSc or PhD within a scientific or related discipline
PREFERRED EXPERIENCE:
- A minimum of 8 years of experience in CMC regulatory affairs
- Experienced in leading CMC regulatory documentation and CMC lifecycle management from IND to marketing applications within the pharmaceutical or biotechnology industry
- Experience with cell therapy is desirable
- Global regulatory experience is preferred but not required
- Minimum 2 years management experience is preferred
KNOWLEDGE, SKILLS AND ABILITIES:
- Knowledge of FDA, EMA and ICH CMC regulations and guidelines for cell therapies
- Proven track record in preparing, reviewing and executing CMC regulatory documents to support clinical studies and marketing applications
- Strong oral and written communication skills
- Demonstrated ability to develop/maintain strong working relationships with the CMC team and cross-functional teams
- Ability to multi-task as needed in a fast-paced start-up environment
- Detail-oriented while also retaining the ability to see the big picture.
- Familiarity with AI-assisted tools for regulatory writing and document drafting (e.g., large language models), with sound judgment on appropriate use, human oversight, and QC of AI-generated content in submission-ready materials.
Skills Required
- Minimum 8 years of experience in CMC regulatory affairs
- Experience leading CMC regulatory documentation and lifecycle management from IND through marketing applications in the pharmaceutical or biotechnology industry
- Knowledge of FDA, EMA, and ICH CMC regulations and guidelines for cell therapies
- Track record preparing, reviewing, and executing CMC regulatory documents for clinical studies and marketing applications
- Strong oral and written communication skills
- Ability to build and maintain strong relationships with CMC and cross-functional teams
- Ability to multitask in a fast-paced startup environment
- Detail orientation combined with the ability to see the big picture
- Familiarity with AI-assisted regulatory writing and document-drafting tools, including large language models, with appropriate human oversight and quality control
- MSc or PhD in a scientific or related discipline
- Experience with cell therapy
- Global regulatory experience
- At least 2 years of management experience
What We Do
We are entering a new era of medicine, where cancer is treated with cellular therapies: living, smart, targeted drugs. While enormous strides have been made, especially in hematologic cancers, the full promise of these therapies still lies ahead. Cell-based immunotherapies have yet to show substantial benefit in solid tumors, which represent the vast majority of cancers. Our goal is nothing less than to develop curative cell-based therapies for solid tumor cancers.
