At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview:

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 seeking a highly motivated Process Development Scientist with expertise in cell cryopreservation and drug product formulation. This role is central to developing robust, scalable, and compliant processes for the final formulation, preservation of cell-based therapies, and on-site handling procedures to ensure seamless integration with cell therapy clinical workflows. The ideal candidate will have hands-on experience with cell handling, cryopreservation techniques, formulation development, and a strong understanding of quality attributes post-thaw.

Roles and Responsibilities

Develop and optimize cryopreservation protocols for various cell types (e.g., iPSCs and iPSC derived cells, engineered cells) to ensure post-thaw viability, functionality, and consistency.

Design and execute formulation studies to establish drug product stability and compatibility with containers and delivery systems.

Conduct small- and scale-up studies for drug product manufacturing, focusing on fill-finish and cold chain logistics.

Collaborate with cross-functional teams including cell process development, analytical development, quality, and manufacturing to ensure seamless integration of drug product processes.

Interface with clinical operations to design handling procedures that ensure reproducible cell product administration at the site.

Support technology transfer to CDMOs.

Author process descriptions, technical reports, SOPs, batch records, and support regulatory submissions (e.g., IND).

Evaluate and implement new technologies and cryoprotectants to enhance product shelf life and usability.

Basic Requirements:M.S. or Ph.D. in Chemical Engineering, Biochemical Engineering, Cell Biology Pharmaceutical Sciences, or a related field.0-3 years (Ph.D.) or 6+ years (M.S.) of relevant experience in cell therapy drug product process development is preferred.Hands-on experience in cell cryopreservation, controlled rate freezing, and thawing protocols; experience with islet cells is a plus.Additional Preferences:

Experience in formulation development for cell products

Familiarity with aseptic processing, fill-finish operations, and container closure systems.

Knowledge of regulatory requirements and CMC considerations for cell-based products

Strong analytical, organizational, and documentation skills.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$133,500 - $217,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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