Sr. Director - mRNA Process Development

Senior Director Of MRNA Process Development

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.

The Bioproduct Research and Development (BR&D) organization strives to deliver innovative medicines to patients through the development and commercialization of monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotides, bioconjugates, and novel gene therapy systems. This organization is a multidisciplinary group that works collaboratively with our discovery, manufacturing and quality, business units.

Position Summary

We are seeking a Senior Director of mRNA Process Development to lead internal and external efforts in advancing our mRNA-based therapeutic production platform from early phase clinical to commercialization. The successful candidate will be responsible for providing strategic and technical leadership in mRNA manufacturing process development including plasmid DNA production, in vitro transcription (IVT), purification, and product characterization. This role requires deep expertise in mRNA process design and optimization, scale up, impurity removal strategies, critical quality attribute (CQA) and control strategy definition, as well as proven ability to manage matrix teams and partnerships across CDMOs, CROs, and internal stakeholders.

Responsibilities :

• Provide technical and strategic leadership for the end-to-end development of robust, scalable, and regulatory-compliant mRNA manufacturing processes.
• Guide microbial fermentation and plasmid DNA production.
• Establish optimized and scalable IVT platforms.
• Drive purification and impurity removal strategies to ensure high product quality and reproducibility.
• Partner with Analytical Development to define CQAs and develop characterization assays.
• Provide scientific oversight, coordinate and manage technology transfer, and troubleshooting for external manufacturing partners.
• Collaborate with cross-functional teams (e.g. Research, Analytical, Drug Product, Clinical and Regulatory) to align process development with clinical and regulatory strategies.
• Lead or support regulatory submissions.
• Support due diligence efforts in business development activities. Mentor and develop a high-performing matrix technical team capable of delivering on program and organizational goals.
• Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement.

Qualifications :

Preferred Capabilities :

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 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.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400. 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.