Director / Sr. Director - 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.

We are seeking a Director / 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.

• 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.

• Ph.D. in Chemical Engineering, Biotechnology, Biochemistry, or a related field with 8-10 years of experience in process development for mRNA-based therapeutics or biologics in the biopharmaceutical industry.
• Proven track record and hands-on experience in process development for plasmid DNA production, IVT, purification, and characterization of nucleic acid products.
• Deep knowledge of mRNA CQAs, impurity profiles and strategies for removal.
• Experience with efficient experiment designs for process optimization, scale up, tech transfer and manufacturing support.
• Proven track record of defining robust control strategy for clinical and commercial manufacturing, successful process validation and regulatory submission (IND, IMPD, BLA, MAA etc.).
• Strong leadership and people management skills; experience overseeing both internal teams and external CDMO/CRO collaborations.
• Excellent communication, ability to effectively lead a cross-functional team, prioritize activities to meet program goals and schedule.

• Deep purification and engineering background
• Familiarity with LNP formulation and drug product considerations.
• Strong regulatory interaction experience (FDA, EMA, other health authorities).

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

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.

#WeAreLilly