Director / Sr. Director - mRNA Process Development

Position Summary

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 provide 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 troubleshoot for external manufacturing partners.
• Collaborate with cross-functional teams (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

• 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, and prioritize activities to meet program goals and schedule.

Preferred Capabilities

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

Compensation and Benefits

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 employees will also 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, 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.

EEO Statement

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.

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