About the position
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. We are looking for a proactive, scientifically grounded Director to lead the development and integration of GMP cell banking, cryopreserved drug product process development, and raw material/media strategy. This role is ideal for a technically strong, cross-functional leader who can operate strategically while also being hands-on. You will play a critical role in enabling our first-in-human studies, and in building the infrastructure to scale into future clinical phases.
Responsibilities
- Establish and lead a unified technical strategy that integrates GMP cell banking, cryopreserved drug product development, raw material control, and media optimization and production to support pre-clinical and clinical programs.
- Oversee the development, qualification, and lifecycle management of iPSC Master and Working Cell Banks, ensuring traceability, testing compliance, and alignment with regulatory expectations.
- Drive the development and scale-up of cryopreserved iPSC derived cell therapy products, including optimization of freezing/thawing protocols, formulation buffers, container-closure systems, and post-thaw performance characterization.
- Lead the implementation of a robust raw material control framework, including sourcing, vendor selection, risk assessments, and change management—ensuring consistency across media, reagents, and critical inputs for development processes.
- Champion the integration of automation and high-throughput technologies where appropriate, to enable efficient and scalable execution across cell banking, media preparation, and formulation workflows.
- Collaborate cross-functionally with Quality, Regulatory, Analytical Development, and Manufacturing (CDMOs) to support CMC documentation, tech transfer, and regulatory submissions (e.g., IND, IMPD).
- Build, lead, and mentor a multidisciplinary team of scientists, engineers, and technical staff while fostering a culture of scientific rigor, operational excellence, and compliance.
Requirements
- Ph.D. or M.S. in Cell Biology, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related discipline.
- Ph.D. 6+ years and M.S. 12+ years of industry experience, including leadership roles in cell therapy, biologics, or regenerative medicine.
Nice-to-haves
- Proven expertise in at least two of the following: GMP cell banking, cryopreservation, media formulation and production, and raw material control.
- Experience supporting early clinical-stage programs and contributing to regulatory submissions.
- Strong understanding of GMP, ICH, and regulatory expectations for raw materials and cell therapy products.
Benefits
- Eligibility to participate in a company-sponsored 401(k); pension.
- Vacation benefits.
- Eligibility for medical, dental, vision and prescription drug benefits.
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
- Life insurance and death benefits.
- Certain time off and leave of absence benefits.
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
