Eli Lilly and Company · 18 hours ago
Senior Advisor, Process Development Engineer, RNA/LNP
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$126K/yr - $205K/yr
2+ years expEli Lilly and Company is a global healthcare leader focused on improving lives through innovative medicines. The Senior Advisor, Process Development Engineer will lead the process development of RNA-lipid nanoparticles and other parenteral drug products, collaborating across functions to ensure successful commercialization of genetic medicine programs.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Design and execute process studies to define clinical and potential commercial manufacturing process for RNA-LNPs and other parenteral drug products
Lead the efforts to drive the process development of various new modalities, especially RNA-LNPs late-stage development, including assessing and mitigating process risks during scale-up through an understanding of in-process and final product critical quality attributes and critical process parameters
Collaborate with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations and work closely with stakeholders to ensure the integration of novel excipients into CMC development timeline and appropriate pathway for regulatory submission
Collaborate with clinical manufacturing team to support clinical manufacturing at internal and/or external CMOs. Author tech transfer related documents and review batch records to ensure accuracy of the manufacturing steps and process parameters. Provide onsite technical oversight of clinical manufacturing to address any technical hurdles during manufacturing
Ensure consistency in technical deliverables and documentation across transfers
Partner with analytical colleagues and aid in the transfer and implementation of analytical methods to CMOs of portfolio molecules for in-process testing and CROs for stability testing
Cross-Functional Collaboration: Represent the product research & development organization on project teams. Partner with cross-functional stakeholders including but not limited to project management, analytical development, quality, device delivery, supply chain, internal/external manufacturing, tech/manufacturing service to define drug product and CMC timeline and key deliverables to meet the requirements for regulatory submission
External Engagement: Establish and leverage strategic relationships with academic and industry partners to adopt new process technologies to accelerate product development
Innovation: Collaborate with early-stage stakeholders to support a strong innovation agenda for the team leading to publications, presentations and industry wide influence. Leverage these innovations to advance the Lilly portfolio
Qualification
Required
Ph.D. Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field and a minimum of 2 years industry experience OR an MS in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field and a minimum of 10 yrs industry experience
Industry experience required includes nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development
Sound understanding of cGMP requirements, ICH and regulatory guidelines is a must
Preferred
Experience with development of RNA-lipid nanoparticle formulation and manufacturing process is highly preferred
Hands-on experience in designing and optimizing manufacturing processes, or drug delivery platforms including RNAs and LNPs is highly preferred
Working knowledge and experience with regulatory submissions of RNA-based therapies is preferred
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
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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