Eli Lilly and Company · 16 hours ago
Director / Sr. Director - mRNA Process Development
Indianapolis, IN
Full-time
Onsite
Director/Executive
$148K/yr - $257K/yr
8+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Senior Director of mRNA Process Development will lead efforts in advancing mRNA-based therapeutic production, providing strategic and technical leadership in manufacturing process development.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Deep purification and engineering background
Familiarity with LNP formulation and drug product considerations
Strong regulatory interaction experience (FDA, EMA, other health authorities)
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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