Eli Lilly and Company · 4 hours ago
Senior Principal Engineer, Technology Transfer and Process Engineering, LNP
US, Indianapolis IN
Full-time
Onsite
Senior Level, Lead/Staff
$66K/yr - $172K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Senior Principal Engineer to contribute to the tech transfer and manufacturing of novel gene editing products, focusing on LNP process development and supporting clinical manufacturing efforts.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Drive technical readiness and on-site support for manufactures of LNP programs. This includes batch record writing and executed record review, process scale-up, process data trending and support of quality activities including change controls, deviation investigations, implementation of process improvements. Lead lessons learned and continuous improvement efforts at vendor sites
Oversee the manufacturing campaigns (on-site) at the CMO, including troubleshooting in close cooperation with the CMO and internal stakeholders. Travel to manufacturing sites will be required
Lead transfer efforts of active clinical processes to secondary vendors to drive supply chain robustness
Coordinate with Supply Chain on sourcing key components and raw materials to support a complex global drug product manufacturing network
Collaborate with cross-functional teams including Process Development, Formulation, Preclinical Toxicology, Analytical Development, Quality Control, Quality Affairs, and External Manufacturing
Write and provide technical review of GMP documents including tech transfer reports, best practices documents, SOPs, technical protocols, manufacturing batch records, campaign summary reports, etc
Write technical reports and contribute to global regulatory filings to support clinical development of Verve’s products
Qualification
Required
MS in engineering or related scientific field with 10+ years experience or BS in engineering or related scientific field with 12+ years experience
Experience with tangential flow filtration required
Knowledge of GMP compliance around drug substance and drug product manufacturing. Understanding of differences in requirements between early-stage and late-stage programs
Attention to detail, critical analysis of data/reports, and troubleshooting abilities
Proven ability to take initiative to achieve results, keep projects on timeline, and find solutions as needed to ensure that project deliverables are met
Domestic and international travel required (up to 25%)
Gap assessment, relationship management, and organizational planning skills required. Ability to clearly communicate risks and potential impacts to both peer groups and management
Expected to be highly proficient in Excel
Preferred
Strong preference for candidates with prior LNP process development experience, including scale-up. Candidates with AAV experience are also encouraged to apply
Proficient in sterile filtration and aseptic processing requirements
Familiar with both early- and late-stage experience in manufacturing
Prior experience with Six Sigma concepts
Proficiency in JMP or similar software
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
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
The Motley Fool
2026-01-25
2026-01-24
2026-01-23
Company data provided by crunchbase